The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas. You will be involved in data management, creation of study related documents and correspondence with internal departments, research sites and our client to ensure a complete and accurate Trial Master File delivery.
We currently offer the exciting opportunity to join the team as Experienced Clinical Trial Coordinator (m/w/d) in full-time and work in home-office throughout Germany.
RESPONSIBILITIES
1. Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
2. Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
3. Assist with periodic review of study files and completeness.
4. Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
5. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
6. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
7. Occasionally conduct Site Qualification Visits or accompany CRAs to visits at study sites / hospitals and support with data review.
8. Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues.
9. May serve as subject matter expert for business processes or lead Clinical Trial Coordinators study teams.
10. May participate in departmental quality or process improvement initiatives.
REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE
11. Bachelor’s or higher-level degree preferable in life science or High School Diploma and apprenticeship in life science, the medical or pharmaceutical field or office management.
12. Previous work experience as Clinical Research Associate is required.
13. Preferrable administrative support experience in clinical research, e.g. as Clinical Trials Assistant, Study Start-Up Assistant.
14. Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
15. Fluent languages skills in German on at least C1 level and good command of English
16. Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
17. Effective communication, organizational and planning skills
18. Ability to work independently and to effectively prioritize tasks while working on multiple projects
19. Ability to establish and maintain effective working relationships with coworkers, managers and clients.
20. Flexibility to business travel - for CRA support and client meetings, in average 2-4 times per month.
We invite you to join IQVIA.
Please apply with your English CV, motivation letter and education certificates and job reference letter.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at