GCP-Service is an independent full-service Clinical Research Organization. Since our foundation in 2004, the company has continuously grown enabling us to deliver the entire spectrum of services required for a successful conduct of clinical trials.
We love what we do and are convinced that our multiple innovative processes as well as our competences and continuous development of our employees provide unique advantages to our company, clients, partners and vendors. Our daily business is based on our company values:

Respect, acceptance and tolerance are the basis of a positive working environment
✓ We think that trust builds sustainability, stability and creativity
✓ We reach a high grade of satisfaction by our flexibility
Reliability must be the basis of a service provider
Fair and honest interactions are the basis of our interpersonal relationships
Continuous professional and personal development enables us to achieve and exceed expectations

Trainee (w/m/d) - Clinical Document Management

We are currently looking for a Trainee to strengthen our Clinical Document Management team in Bremen. The successful candidate will have the opportunity to work in a multidisciplinary team contributing to international clinical research projects.
She/he will support the management of (electronic/paper) Trial Master Files and study documentation in the context of clinical trials which allows verification of the conduct of a clinical trial and the quality of the data generated. The successful candidate shall play a vital role to ensure data integrity and works according to Standard Operating Procedures (SOPs) of GCP-Service or sponsor, ICH/GCP guidelines and applicable laws and regulations.

Preferred qualifications:

  • At least B.Sc. in a discipline relevant to clinical research or any equivalent qualification
  • Excellent planning, organizational and time management skills
  • Attention to detail and the ability to work individually within a multi-disciplinary team
  • Proficient computer skills including Microsoft Word, Excel, and PowerPoint
  • Proficient presentation skills (e.g. internal trainings)
  • Fluency in English & German

Responsibilities can include:

  • Support the management of study documents / TMFs
  • 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)
  • 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, especially regarding the handling of the eTMF

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

Benjamin Tsiflidis
GCP-Service International Ltd. & Co.KG
Anne-Conway-Str. 2
28359 Bremen
Phone: +49 (0) 421 89676615
Fax: +49 (0) 421 4348659