Reference Number: JO-2011-458814
TMF Study Lead
Rate: £40,000 – 42,000
Job Type: Permanent
Location: City

TMF Advisor – 12 Month FTC
Home Based (Anywhere in the UK)
Salary: Up to 42k + Benefits

An exciting position for a TMF Specialist, with experience in implementing and developing TMF solutions has opened at aglobal leader in document management solutions within clinical research. This is a great opportunity for a TMF Advisor to join them as aSubject Mater Expert on a 12 month FTC as part of their Specialist Services Team.

Key Responsibilities:

– Manage TMF process for key biotech client
– Create Trial Master File specifications according to client’s needs
– Provide guidance, clarification, and strategy for regulatory requirements and compliance
– Drive process improvement initiatives for the client
– Support inspection and audits, including preparedness and being a point of contact forTMF related questions during the inspection
– Ensure timelines and document quality standards are met and provide corrective actionswhen necessary.
– Attendance to London office 1-2 times monthly

Required Experience:

– At least 2 years TMF/eTMF experience within a Pharma/CRO/Biotech or Academia
– TMF Specialist/Lead/Study Owner experience
– Use of Veeva eTMF software
– Strong written and verbal communication skills
– Ability to work autonomously as well as part of a team
– Full TMF lifecycle document management experience (Paper/Electronic)

This is a fully home-based position, anywhere in the UK. While this is a 12 month FTC, there is potential for the role to become permanent. The successful applicant will be rewarded with a competitive salary and benefits as well as an opportunity to work for a global leader.

If this role is of interest and you are available for a remote interview (via Microsoft Teams or Skype) within the next week, please send your cv to robert.henry@cpl.com.

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