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TMF Manager

2 months 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, BioPharmaceutical Division. As a TMF Manager, you will play a critical role in managing Trial Master Files (TMFs) and Sponsor Oversight Files (SOFs) for all studies, ensuring compliance with ICH-GCP and other regulatory requirements.

Key Responsibilities:
  • Manage TMFs and SOFs for all studies, ensuring compliance with ICH-GCP and other regulatory requirements.
  • Work closely with Clinical Project Managers to organize and execute clinical trial activities.
  • Schedule meetings and manage travel arrangements.
  • Attend and participate in company audits or regulatory inspections as required.
  • Support project teams through (e)TMF and study document management, vendor management, and regulatory and ethics submissions.
Requirements:
  • 7+ years' experience managing TMFs in a Clinical Operations environment, in the pharmaceutical, biotech, or CRO industry, working with ICH/GCP guidelines.
  • Experience in QC, maintenance of trial tracking sheets and databases, and preparing documentation for archiving.
  • Proven ability to work under pressure to meet project deadlines.
  • Exposure to Veeva Vault and other document management systems.
  • Excellent communication and interpersonal skills, strong organization and time management skills.
  • Proficient in Word, Excel, and PowerPoint.
About The RFT Group:

The RFT Group, BioPharmaceutical Division, specializes exclusively in the recruitment of scientists, engineers, and executives for the biotechnology, pharmaceutical, and medical device sectors.