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Trial Master File Manager

United States   •  Negotiable  •  Permanent, Full time


Trial Master File Manager

Location: Pennsylvania or Maryland

CPL Life Sciences are working with a global biotechnology company focused on the development of novel therapeutics designed to treat a range of diseases including within oncology and infectious diseases. This is an exciting time to join them as one of their products has recently demonstrated an overall survival benefit within trials where the condition has been insensitive to previous immunotherapies.

The purpose of this role will be to take responsibility for the TMF processes including implementation and overall management of the TMF systems.

Key responsibilities:

  • Acting as the primary point of accountability for the Trial Master File processes and systems
  • Developing global standards, standard operating procedures and corresponding controlled documents
  • Evaluating, implementing, and managing the eTMF system and TMF operations
  • Developing, reviewing, and approving study-specific TMF procedural documents and TMF management plans
  • Conducting inspection readiness checks/quality reviews of TMF documents
  • Developing, implementing, and providing standard TMF metrics
  • Taking ownership of the eTMF system
  • Managing and maintaining the system
  • Developing and implementing tools and processes to support the eTMF system
  • Identifying, evaluating, and implementing archival vendors and processes for the Trial Master File
  • Representing the TMF operations function at meetings and on study teams

Requirements:

  • A degree in a relevant discipline
  • Extensive experience working with TMF systems (ideally Veeva Vault)
  • Experience working in a pharma, biotech or CRO environment
  • Vendor management experience
  • Experience managing people or contracted resources

If you would like to hear more, please apply within or send your CV to Rhianna.bellamy@cpl.com

  • Agency: Cpl Life Sciences
  • Contact: Rhianna Bellamy
  • Reference: JO-2109-477051
  • Posted: 24th September 2021
  • Expires: 22nd October 2021

Cpl Life Sciences

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