Reference Number: JO-2302-510585
TMF Manager
Rate: Negotiable
Job Type: Contract
Location: Central London / West End

TMF Manager

12 month contract

Central London

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 contract with the potential opportunity for an extension.

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 therapy areas.

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

If the above is of interest to you then please apply here, or email your CV to sarah.phillips@cpl.com.

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

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