Tmf Manager

TMF Manager

12 month contract

Amsterdam

Full time
- 2 days onsite, 3 days remote working

CPL Life Sciences have partnered with a research driven global pharmaceutical company who require additional support within their Clinical Study team, being the sole point of contact for TMF and eTMF oversight and management. This is a 12 month initial contractwith the potential opportunity for an extension or permanent role.

This role will require someone with excellent knowledge of ICH-GCP guidelines, regulatory body guidelines and working knowledge of clinical study documentation. You will have the opportunity to work on studies from phase I-III across a number of therapyareas.

Key responsibilities may include:

- Manage document control processes and systems for GCP activities in compliance with internal procedures, policies and regulatory requirements
- Provide TMF business guidance
- Help lead the process of developing a global TMF structure
- Discuss the TMF status of each study and provide resolutions to any maintenance/management related questions
- Assist in updating TMF related SOPs and plans
- Ensures high quality TMF set-up and management (onboarding of study contributors, completion of the TMF management plan, study specific preparation of documents in the system, periodic reviews, etc.)
- Prepare regular metrics and status reports on document control
- Train and mentor study teams in TMF documentation
- Assist with any TMF queries from the clinical study team

Trial Master File - TMF - TMF Manager - Clinical Study Support