We are currently looking for a TMF Manager (w/m/d) to strengthen our Clinical Document Management team in our head quarter in Bremen.

The successful candidate will have the opportunity to work in a multidisciplinary team contributing to international clinical research projects. She/he will be in charge to manage (electronic/paper) TMFs and study documentation of clinical trials. He/she prepares and maintains the TMF to allow verification of the conduct of a clinical trial and the quality of the data generated.

Preferred qualifications:

• completed education / work experience in an administrative area (clinical, business administration, etc.) or scientific background
• Excellent planning, organizational and time management skills
• Attention to detail and the ability to work individually
• Proficient computer skills including Microsoft Word, Excel, and PowerPoint
• Proficient presentation skills (e.g. internal trainings)
• Fluency in German & English

Required qualifications:

• Serve as main administrator of the eTMF (including electronic Investigator Site File)
• Manage study documents and ensure they are quality checked, correctly named and filed in TMFs in due time
• Plan and perform periodical reviews of TMF files to assess their completeness and quality and communicate status updates to the study team to address and resolve any filing issues
• Actively engage study teams and external resources to ensure the receipt, processing and tracking of all study-related documentation
• Preparation and shipment of clinical study supplies and documents to study sites and sponsors
• Provide TMF trainings to clients and study teams to ensure study documents are processed adequately and per SOP and study-specific TMF management plans
• Prepare and ship the TMF for archiving according to statutory retention periods and requirements
• Assist Project Managers and study teams in executing assigned clinical trial activities (e.g. create and maintain trackers, generate meeting minutes, etc.)
• Assist the study team in the submission of clinical trial applications to Ethic Committees and Competent Authorities
• Contribute to the continuous development of departmental procedures

If you are interested, send us your electronic application (with your earliest start date) and your CV to:

Alvi Vincent / Katharina Zacher-Aued
GCP-Service International Ltd. & Co.KG
Anne-Conway-Str. 2
28359 Bremen
Germany

Phone:

• Alvi Vincent: +49 (0) 421 89 67 66 33
• Katharina Zacher-Aued: +49 (0) 421 20 80 98 84

Fax: +49 (0) 421 4348659
E-mail: application@gcp-service.com