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TMF Manager

2 months ago

London, Greater London, United Kingdom The RFT Group Full time
{"title": "TMF Manager", "description": "Job Summary

We are seeking a highly skilled TMF Manager to join our Clinical Development and Operations team. As a key member of our team, you will be responsible for managing TMFs, Sponsor Oversight Files, and archiving for all studies according to ICH-GCP and other regulatory requirements.

Key Responsibilities
  • Manage TMFs, Sponsor Oversight Files, and archiving for all studies
  • Work closely with Clinical Project Managers to organize and execute clinical trial activities
  • Liaise with multiple stakeholders, including investigational site staff, regarding end of trial archiving requirements
  • Schedule meetings and manage travel arrangements
  • Participate in team meetings, including cross-functional team meetings and meetings with third-party vendors
Requirements
  • Bachelor of Science degree preferred
  • 7+ years' experience managing TMFs in Clinical Operations environment
  • Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model
  • 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
About Us

The RFT Group is a specialized recruitment agency that provides high-quality candidates to the biotechnology, pharmaceutical, and medical device sectors.

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