Reference Number: JO-2302-510585
Job Type: Contract
Location: Central London / West End
12 month contract
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 email@example.com.
Trial Master File – TMF – TMF Manager – Clinical Study Support