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Trial Master File Specialist

United States   •  Negotiable  •  Permanent, Full time


Trial Master File Specialist

Location: Pennsylvania

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 provide support for the TMF activities to support the clinical teams. This will involve the set up and management of the TMF as well as creating, reviewing and approving TMF plans.

Key responsibilities:

  • Managing and maintaining eTMF systems
  • Assisting with or leading training on Clinical Document Management and TMF systems
  • Representing TMF Operations function on study teams
  • Creating and reviewing TMF related SOPs and procedural documents, TMF Plans, and associated documents
  • Managing and maintaining document rooms, including supporting filing, scanning, QC, and inventory of paper documents
  • Supporting audits and inspections
  • Participating in or leading TMF governance meetings with vendors
  • Working closely with study teams to help escalate and resolve issues identified as a result of reviews
  • Supporting archiving, document collection and processing, or start-up activities as required

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
  • Thorough knowledge of ICH-GCP guidelines

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-2109-477048
  • Posted: 24th September 2021
  • Expires: 22nd October 2021

Cpl Life Sciences

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