Tmf Manager - Amsterdam, United Kingdom - Cpl Life Sciences

Cpl Life Sciences
Cpl Life Sciences
Verified Company
Amsterdam, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
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 setup 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
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