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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. As a key member of our Clinical Operations team, you will be responsible for 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 accuracy and completeness
  • Collaborate with Clinical Project Managers to organize and execute clinical trial activities
  • Develop and maintain project-specific oversight plans and tracking tools
  • Ensure compliance with ICH-GCP and other regulatory requirements
  • Provide support to project teams through eTMF and study document management, vendor management, and regulatory submissions
Requirements:
  • Bachelor of Science degree preferred
  • 7+ years' experience managing TMFs in Clinical Operations environment
  • Experience with Veeva Vault and other document management systems
  • Excellent communication and interpersonal skills
  • Strong organization and time management skills

We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for Clinical Operations, we encourage you to apply for this exciting opportunity.