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 *home-based throughout Germany*.
- 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.*
- 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.
- Assist with periodic review of study files and completeness.*
- Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.*
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues.
- May serve as subject matter expert for business processes.*
- May lead Clinical Trial Coordinators study teams.*
- May participate in departmental quality or process improvement initiatives.
- May occasionally accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE:
- Bachelor’s or higher-level degree preferrable in life science *or* High School Diploma and apprenticeship in life science, the medical or pharmaceutical field or office management.
- 3-5 years of administrative support experience in clinical research, e.g. as Clinical Trials Assistant, Project Assistant, inhouseCRA, Study Start-Up Assistant.
- Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluent languages skills in German on at least C1 level and good command of English*
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint*
- Effective communication, organizational and planning skills*
- Ability to work independently and to effectively prioritize tasks while working on multiple projects*
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
We invite you to join IQVIA™. Why join us?*Ongoing development is vital to us enabling you to have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.
- Our benefits package is competitive, our scope is international, and we genuinely care about our people and their success.
- Occasional home-office is possible.
Whatever your career goals, we are here to ensure you get there!*
Please apply with your English CV, motivation letter and your certificates and reference letters.
LI-KA1IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.
Learn more at https://jobs.iqvia.com (https://jobs.iqvia.com/)