TMF Manager

7 days ago


London, Greater London, United Kingdom The RFT Group Full time
TMF Manager Job Description

We are seeking a highly skilled TMF Manager to join our team at The RFT Group, a leading recruitment agency specializing in the biotechnology, pharmaceutical, and medical device sectors.

Key Responsibilities:

  • Manage TMFs, Sponsor Oversight Files, and Archiving for all studies according to ICH-GCP and other regulatory requirements.
  • Work closely with Clinical Project Managers across Phase I-III trials, covering multiple responsibilities of outsourced operational activities.
  • Line manage, coach, and develop TMF Specialists.
  • Provide vendor oversight (CROs, etc.) Clinical Study operational activities and present study tracking, progress reporting to CTMs and Leadership team.

Requirements:

  • Bachelor of Science degree preferred.
  • 7+ years' experience managing TMFs in Clinical Operations environment, in the pharmaceutical, biotech, or CRO industry working ICH/GCP guidelines.
  • Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model and applicable industry guidelines.
  • Proven ability to work under pressure to meet project deadlines.
  • Excellent communicator of technical and scientific information.
  • Excellent interpersonal skills, strong organization skills, and time management skills.
  • Strong attention to detail required.
  • Proficient in Word, Excel, and PowerPoint.

About The RFT Group:

The RFT Group is a specialist recruitment agency dedicated to the biotechnology, pharmaceutical, and medical device sectors. We pride ourselves on our expertise and ability to provide high-quality candidates to our clients.


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