Location: Hertfordshire, England
Industry: Pharmaceuticals
Rate: £40000 - £49000 per annum
Job Type: Permanent

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
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice http://www.allegisgroup.com/Privacy/Default.aspx). By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.

About Aerotek:

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.

Contact Information:

Abigail Fox
TEL : +44 (0) 207 532 7948

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