Clinical Trial Document Specialist / Trial Master File Manager (part-time / full-time) (m/f/d) in Bremen

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