Overview of salaries statistics of the profession "Associate Director Of Education in UK"

Location: Poland- Home based        Schedule: Freelance, Various FTEs                                    CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Poland. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                Join our team and help us deliver clinical trials that will improve patients' lives.        Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Germany- Home based        Schedule: Freelance, Various FTEs                                  CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Germany. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                Join our team and help us deliver clinical trials that will improve patients' lives.        Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Spain - Home based          Schedule: Freelance, Various FTEs                                      CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Spain. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                    Join our team and help us deliver clinical trials that will improve patients' lives.            Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process     Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.            If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.          Who will you be working for?          About CROMSOURCE        CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos     Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.          CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.          Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Germany- Home based        Schedule: Freelance, Various FTEs                                     CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Senior Clinical Project Manager,  You will be working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies.       As a Senior Clinical Project Manager, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                         Join our team and help us deliver clinical trials that will improve patients' lives.        Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDelivering  project specific trainingsOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager,  and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with and enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation                         Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, Project Management, Study ManagementLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Poland - Home based        Schedule: Freelance, Various FTEs                                    CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager I, to join their clinical operations team in Poland. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects.   Join our team and help us deliver clinical trials that will improve patients' lives.                   Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators and coordinating the project team memberOversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical stateManages the budget of the projectParticipates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the SponsorSupervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulationsUndertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levelsMay provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activitiesSupervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projectsMay act as Feasibility Associate (FEA) after appropriate and documented trainingMay prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them Education and Experience:University Degree in scientific, medical, or paramedical disciplinesUp to three 3 years of project management experience in the CRO/Pharmaceutical industryStrong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Europe - home-basedSchedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture.  We are recruiting for a dynamic person to join our in-house team as a Director of Business Development - PV, MA & RA Services. You will be responsible for lead generation, opportunity assessment, creating new accounts, and growing existing accounts. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Identify, assess, and pursue new business opportunities.Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.Work to exceed revenue targets that align with the company's growth objectives. Education and Experience:6+ years of sales and account management experienceExperience in functional and consultancy sales with a particular focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory AffairsEstablished a network of decision-makers in the life-sciences industry.Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.Strong negotiation skills with a proven track record of closing complex business dealsPersuasive and compelling presentation and communication skills, both written and verbalAbility to interpret business challenges and present quick and responsive high-level solutions.Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.Positive employer and client referencesBA, MBA, or equivalent experience The Application ProcessOnce you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.  If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact [email protected] for more information. Who will you be working for? About CROMSOURCE   CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                Our Company EthosOur employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry-average turnover rates. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account managementSkills: Business Development Director, Business Development Manager, Clinical Research Associate, Business Development, clinical trials, CROLocation: EuropeShare: LinkedIn Facebook Twitter Email

Location: Netherlands - Home based  Schedule: Permanent, Full-time                       Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their internal team in Netherlands. This role is a full-time permanent opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                                 As a Senior Clinical Project Manager, you will be responsible for managing the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations.                         Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projects.Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.Knowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.Assure the proper timelines of the assigned projects.Manage the budget for the project.Monitor the workload and the performance of the project team.Plan and monitor the tasks of the team in the specific areas.Coordinate the Clinical Research Associates and Clinical Monitors activity.Collaborate with he Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activities.Assist the Medical Monitor in preparing protocols, Case Report Forms and final Clinical Study ReportsDeliver project specific trainings.Organise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetings.Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.Inform the Project Director/Leader about any issues.Perform co-monitoring visits for the assigned clinical projects as necessary.Act as a tutor for Project Coordinators and Project Manager IMaintain relationships with the Sponsor, including providing project updates.Prepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying and enforcing Company procedures. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similar.Excellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Benefits of Working in Netherlands:Competitive SalaryGroup health insuranceGreat pension scheme24 vacation daysInternet reimbursementCompany Car with fuel card depending on the function.Dedicated Line Manager The Application Process         Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step. If you would like to discuss the role before applying through the website @

Location: Italy - Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Italy. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                               Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel. The Benefits of Working in Italy:· Meal vouchers· Mobile phone if requested by the Line Manager· Dedicated Line Manager Who will you be working for?                                    About CROMSOURCE                       CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                    Our Company Ethos                  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                     The Application Process                  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.               If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                        CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                     Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Spain - Home-based          Schedule: Permanent, Full-time                         Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Spain. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                                  As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.                   Join our team and help us deliver clinical trials that will improve patients' lives.                                         Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel  The Benefits of Working in Spain:Competitive SalaryHealth insuranceHome office allowanceMeal vouchers23 days of holiday per yearDedicated Line Manager Who will you be working for?                                             About CROMSOURCE                            CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                              Our Company Ethos                       Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                             The Application Process                       Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.                       If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                                  CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                             Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, Senior Clinical Trial Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Belgium - Home based    Schedule: Permanent, Full-time                           Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their internal team in Belgium. This role is a full-time permanent opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                                  As a Senior Clinical Project Manager, you will be responsible for managing the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations.                             Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projects.Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.Knowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.Assure the proper timelines of the assigned projects.Manage the budget for the project.Monitor the workload and the performance of the project team.Plan and monitor the tasks of the team in the specific areas.Coordinate the Clinical Research Associates and Clinical Monitors activity.Collaborate with he Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activities.Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project specific trainings.Organise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetings.Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.Inform the Project Director/Leader about any issues.Perform co-monitoring visits for the assigned clinical projects as necessary.Act as a tutor for Project Coordinators and Project Manager IMaintain relationships with the Sponsor, including providing project updates.Prepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying and enforcing Company procedures. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similar.Excellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Benefits of Working in Belgium:Competitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursement The Application Process           Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.                        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please send an mail to: [email protected] for more information.                     Who will you be working for?                                            About CROMSOURCE                           CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus on the heart of everything we do.                                                            Our Company Ethos                      Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.                                                         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                             Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research OrganisationSkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Germany- Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Germany. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                                 Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel. The Benefits of Working in Germany:30 Euro net Internet cost reimbursement per monthAdditional Accident Insurance, fully covered by the company.25 vacation daysPossibility of salary conversion for additional pension insuranceDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviewsTeam events and end-of-year partyCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement. Who will you be working for?                                    About CROMSOURCE                        CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                      Our Company Ethos                  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                     The Application Process                  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.               If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                          CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                     Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Trial Manager, clinical trials, CRO, Medical Devices, Project Leadership, Project ManagementLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Belgium - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Netherlands - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writingSkills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: NetherlandsShare: LinkedIn Facebook Twitter Email

Location: Germany - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Outsourcing, PharmacologyLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: United Kingdom - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team membersRead, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.  Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, CRO, Medical Writing, Outsourcing, PharmacologyLocation: United KingdomShare: LinkedIn Facebook Twitter Email

Location: Poland - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writingSkills: Medical Writer, CER, CRO, Medical Writing, Outsourcing, PharmacologyLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Spain - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team membersRead, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.   About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: SpainShare: LinkedIn Facebook Twitter Email

Job summary The Assessment Coordinator is responsible for the operational processes governing assessment including assessment boards, exam invigilation and academic misconduct panels. The role holder will process, maintain and update assessment data, ensuring information is processed in accordance with academic regulations and procedures, and will contribute to the development and updating of assessment-related policies and procedures. The Assessment Coordinator will support the Registrar, Academic and Student Services Manager and the wider academic Faculty in the effective management and implementation of operational processes for assessment and conferment. They will provide specialist advice on the application of assessment regulations and procedures to a wide range of stakeholders including Programme Leaders, Director of Education, Tutors and across various professional service teams. The role holder will also provide dedicated secretarial support to a range of panels, committees, boards and any working groups. Key responsibilities Coordinate a wide range of administrative processes associated with assessment and conferment. Act as a main point of contact with the School’s validating partners in relation to assessment processes, assessment data and certification. Coordinate written examinations, including exam schedules and invigilation arrangements, ensuring compliance with assessment regulations. Manage records of academic misconduct and academic appeals, reporting to academic committees as required. Minute academic misconduct panels, extenuating circumstances panels and appeals panels and support the preparation and conduct of these meetings. Attend all module assessment, progression and award boards, coordinating the preparation for these meetings, compiling papers, checking the accuracy of data and amending any data entry errors. Perform data entry and updating tasks and ensure all marks and relevant assessment data are correctly recorded and submitted on schedule on relevant systems and templates, contributing to accurate data returns and ensuring data integrity. Ensure all assessment outcomes following module, progression and award boards are correctly recorded and where necessary updated on the student record system liaising with the academic and student services team. Support processes relating to the conferment of awards and issue of transcripts and certificates to graduates. Coordinate the schedule for External Examiner visits, liaising directly with External Examiners regarding the detailed arrangements for these visits and the scrutiny of work. Contribute to the development of the SINAPTO improvement project and Tribal project in terms of the specification to support the accurate processing of assessment data and academic conferment. Ensure and maintain the secure storage and archiving of examination scripts, assessment records and student feedback. Develop and update operational procedures, guidance documents and templates to support the efficiency and integrity of the assessment process. Support the implementation of reasonable adjustments including the provision of additional time in examinations in conjunction with Academic and Student Services. Work collaboratively with Student and Academic Services, Registry and Faculty staff to support, maintain and improve operational procedures governing the assessment process. Any other duties commensurate with the level of the post and relevant cross School activities throughout the including induction, graduation and training/briefing events. Knowledge and Skills required Essential Undergraduate degree Ability to work in a team and collaboratively across the School Ability to work accurately and consistently within prescribed deadlines Ability to work in a busy environment Relevant experience of assessment administration preferably within education Excellent communication and interpersonal skills Proficient IT skills Awareness of data protection Ability to maintain confidentiality and follow prescribed procedures Desirable Minuting or committee servicing experience Interest in fashion Previous experience of working in higher education

Overview: We’re Kingfisher, A team made up of over 82,000 passionate people who bring Kingfisher - and all our other brands: B&Q, Screwfix, Brico Depot, Castorama and Koctas - to life. That’s right, we’re big, but we have ambitions to become even bigger and even better. We want to become the leading home improvement company and grow the largest community of home improvers in the world. And that’s where you come in. At Kingfisher our customers come from all walks of life, and so do we. We want to ensure that all colleagues, future colleagues, and applicants to Kingfisher are treated equally regardless of age, gender, marital or civil partnership status, colour, ethnic or national origin, culture, religious belief, philosophical belief, political opinion, disability, gender identity, gender expression or sexual orientation. We are open to flexible and agile working, both of hours and location. Therefore, we offer colleagues a blend of working from home and our offices, located in London, Southampton & Yeovil. Talk to us about how we can best support you! We're recruiting for a forward-thinking Company Secretarial Assistant to join the Group Company Secretariat team. This role would suit someone with 1-3 years’ relevant company secretarial experience within a large UK listed company and who has recently embarked on the Chartered Governance Qualifying Programme. Based in Paddington, the role will involve exposure to the full range of FTSE 100 PLC activities, in addition to varied UK and international subsidiary work. What's the job?: Support the Secretariat Team as required in delivering a quality service to all Board and Executive level Committees including: collating and publishing papers, managing forward planners and meeting secretary duties as required. Assisting with statutory compliance for the Group and its UK subsidiaries. Support the delivery of the Group’s MAR compliance procedures. including reviewing and maintaining the insider and restricted lists, the dealing policy, insider and restricted guidance and training materials, and all associated communications. Support in drafting the AGM materials including the notice of meeting, ancillaries, and collate and publish the Directors’ briefing pack. Working with the other Company Secretarial Assistant in drafting and communicating a quarterly internal corporate governance update to internal stakeholders, including at Director-level. Involvement in ad hoc corporate projects including progressing the Shareholder Strategy and supporting changes to Kingfisher’s internal governance arrangements, particularly those owned by the Group Company Secretariat team. Supporting maintenance of the integrity of Group Company Secretariat’s presence on the Kingfisher plc website and on the intranet. What you'll bring: Relevant company secretarial experience within a UK listed company, preferably FTSE 100 or FTSE 250 Working knowledge of the UK Companies Act, UK Corporate Governance Code, UK disclosure, transparency and listing rules and UK Market Abuse Regulations Currently studying on the Chartered Governance Qualifying Programme (study support available) Degree level education preferable Prior experience with GEMs and Diligent Boards preferable At Kingfisher, we value the perspectives that any new team members bring, and we want to hear from you. We encourage you to apply for one of our roles even if you do not feel you meet 100% of the requirements. In return, we offer an inclusive environment, where what you can achieve is limited only by your imagination! We encourage new ideas, actively support experimentation, and strive to build an environment where everyone can be their best self. We also offer a competitive benefits package and plenty of opportunities to stretch and grow your career. Interested? Great, apply now and help us to Power the Possible #LI-HV1

Job Number 23143148 Job Category Information Technology Location JW Marriott Grosvenor House London, 86-90 Park Lane, London, London, United Kingdom VIEW ON MAP Schedule Full-Time Located Remotely? N Relocation? N Position Type Non-Management EXPLORE MARRIOTT Marriott International portfolio of brands includes both JW Marriott and Marriott Hotels. JW Marriott is part of Marriott International's luxury portfolio and consists of more than 110 beautiful properties in gateway cities and distinctive resort locations around the world. JW believes our associates come first. Because if you’re happy, our guests will be happy. It’s as simple as that. Our hotels offer a work experience unlike any other, where you’ll be part of a community and enjoy a true camaraderie with a diverse group of co-workers. JW creates opportunities for training, development, recognition and most importantly, a place where you can really pursue your passions in a luxury environment. Treating guests exceptionally starts with the way we take care of our associates. That’s The JW Treatment™. Grosvenor House Located on Park Lane in the heart of Mayfair, our distinguished 5-star hotel offers exceptional accommodation, epicurean delights and sweeping views over Hyde Park. This grand 5-star hotel celebrated its 90th anniversary in 2019. JW Marriott Grosvenor House London welcomes celebrities, royalty and business leaders to Mayfair throughout its history and continues to do so. London is on the doorstep, the hotel is a stone’s throw from Bond Street, Knightsbridge, Regent Street, Buckingham Palace, V&A, Natural History & Science museums and the West End. Our guests are able to experience modern luxury in a place where they can be mindful and present, and indulge in the inspired service and nourishing surroundings. We are currently recruiting for an IT Technician. Join our amazing and diverse team and grow your career with Marriott International, the world’s largest and most celebrated hospitality brand. POSITION SUMMARY The Systems Technician contributes advanced knowledge and skill in technology and general hospitality business knowledge to support business and technology objectives. The systems technician will be responsible for assisting hotel management with IT implementation and maintenance. Provide support as part of the IT defined support plan, participating in appropriate coverage for the support of systems 24 hours a day 7 days a week. They are responsible for ensuring that the hotel based technology is installed to required standards and to maintain security compliance. The Systems technician interfaces with Vendors, iT , SSC and hotel associates. The IT Systems Manager will report to Director of Rooms with a dotted line to the Senior Manager IT Field Services SSC hotels. EXPECTED CONTRIBUTIONS Previous experience of hotel operations preferable Knowledge of hotels systems, Opera, Micros, etc Ensures hotel technology is compliant with Marriott International Policies and Information Security manual. Maintains Inventory of applications and Hardware. Acts as hotel liaison for Information Technology vendors. Provides escalation support for out of SLA issues for on property systems. Assists in resolving complex support issues that may involve multiple vendors and systems as part of the defined support processes. Reinforces communication to property management relating to IT Policies & Projects. Assists in managing technology/asset life- cycle for the hotel. Provides end user support to hotel associates as defined by the support processes. Manages PC moves/adds and changes, migrating /restoring data when necessary Creates and maintains a secure and clean computer room Applies Security and Operating systems patches as directed by corporate and continental technical leads. Assists the conference team in Internet set up in the conference area, engaging with the customer to ascertain requirements and liaising with the GPNS vendor to ensure customer requirements are fulfilled. CANDIDATE PROFILE - KEY TALENTS AND EXPERIENCE DESIRED REQUIRED: 1 – 3 years IT experience gained in the hospitality industry Excellent problem solving skills Experienced in network hardware, desk top, peripheral, protocols, communications, operating systems PREFERRED SKILLS AND KNOWLEDGE: Experience with Marriott Internal Applications (MARSHA, Opera PMS, Sales & Catering, Etc.) Hotel operational experience and demonstrated hospitality skills Technical Skills/Computer: Windows Microsoft Active Directory Microsoft Office 365 Opera & Micros Technical Skills/Other: Knowledge of IT operating standards Trouble shooting & resolution skills for PCs, operating systems, servers, peripherals, etc Excellent written and verbal communication skills, with ability to communicate technical solutions to non-technical managers. Systems Support Education and Professional Certification: IT related NVQ or equivalent work experience. REWARDS FOR WORK… BENEFITS FOR YOUR LIFESTYLE As a world-class leader in the travel industry, there’s no better place than Marriott International to make your mark. Joining us, you’ll get to entertain and meet people from all over the world as you build your experience. You’ll find a place where your personality and ideas are appreciated just as much as the work you do. You’ll grow through opportunities to explore the business, opening yourself to various career options. If you have the natural ability to communicate and enjoy working with others, we welcome you to join our global family. We’ll support you in and out of the workplace by offering: Team-spirited co-workers Encouraging management Wellbeing programs Comprehensive Training and Development program Marriott Discount Card enabling to benefits from hotel room, gift shops and Food and Beverage Recognition programs Meals at work Uniform Enrolment of Perks at Work - Access to unlimited deals of retailers and more 20 days holiday increasing with service Cycle to work scheme Pension & Life Assurance Awards and recognition celebrations and many more…. Our highest priority is making you feel as welcome as our guests. We want you to know you’re important to us and that you’ll make an impact in your role, and for that, you’ll be appreciated and valued. In line with the Asylum and Immigration Act 1996, we do require all applicants to have the eligibility to live and work in the United Kingdom. Documentation will be required. Marriott International is an equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any other basis covered under applicable law. Marriott Hotels strive to elevate the art of hospitality, innovating at every opportunity while keeping the comfort of the oh-so-familiar all around the globe. As a host with Marriott Hotels, you will help keep the promise of “Wonderful Hospitality. Always.” by delivering thoughtful, heartfelt, forward-thinking service that upholds and builds upon this living legacy. With the name that’s synonymous with hospitality the world over, we are proud to welcome you to explore a career with Marriott Hotels. In joining Marriott Hotels, you join a portfolio of brands with Marriott International. Be where you can do your best work, begin your purpose, belong to an amazing global team, and become the best version of you. JW Marriott is part of Marriott International's luxury portfolio and consists of more than 100 beautiful properties in gateway cities and distinctive resort locations around the world. JW believes our associates come first. Because if you’re happy, our guests will be happy. JW Marriott associates are confident, innovative, genuine, intuitive, and carry on the legacy of the brand’s namesake and company founder, J.Willard Marriott. Our hotels offer a work experience unlike any other, where you’ll be part of a community and enjoy true camaraderie with a diverse group of co-workers. JW creates opportunities for training, development, recognition and most importantly, a place where you can pursue your passions in a luxury environment with a focus on holistic well-being. Treating guests exceptionally starts with the way we take care of our associates. That’s The JW Treatment™. In joining JW Marriott, you join a portfolio of brands with Marriott International. Be where you can do your best work, begin your purpose, belong to an amazing global team, and become the best version of you.