TMF Management and compliance Manager Job Description:
The TMF manager is responsible for overseeing the daily global management activities ensuring the integrity of the Trial Master File (TMF), reporting to the Head of TMF process management and Quality Control.
- Education to B.Sc. level or equivalent, preferably in a scientific discipline
- Demonstrated experience in the pharmaceutical industry, preferably in regulatory operations or clinical development/operations
- Experience with Clinical Document Management, TMF, and/or Clinical Quality Control desired
- Supervisory/line manager experience required
- Must have a detailed knowledge of domestic and international regulatory requirements (including ICH and GCP guidelines)
- Must have strong knowledge of and be able to differentiate all key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents).
- Must have good understanding of the clinical development process
- Knowledge/understanding of technologies to support document collection and archiving
Aerotek® is a leading provider of technical, professional and industrial recruiting and staffing services. We do not provide engineering services directly but specialise in locating and placing qualified engineers with customers who are seeking their skills. Aerotek is a division of Allegis Group Limited, a wholly owned subsidiary of Allegis Group® Inc., the fourth largest staffing company in the world. Allegis Group Ltd is an Employment Business and Agency. Aerotek operates a network of more than 150 non-franchised offices, employing 2,000 recruiters to identify, screen and select top talent.
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