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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, a leading recruitment agency specializing in the biotechnology, pharmaceutical, and medical device sectors.

Key Responsibilities:

  • Manage Trial Master Files (TMFs) and Sponsor Oversight Files (SOFs) for all studies, ensuring compliance with ICH-GCP and regulatory requirements.
  • Work closely with Clinical Project Managers to organize and execute clinical trial activities, including vendor management and regulatory submissions.
  • Develop and implement effective document management systems, including electronic archiving and indexing.
  • Provide training and support to TMF Specialists, ensuring they have the necessary skills and knowledge to perform their roles effectively.
  • Collaborate with cross-functional teams to ensure seamless project execution and compliance with regulatory requirements.

Requirements:

  • Bachelor of Science degree in a relevant field.
  • At least 7 years of experience in managing TMFs in a clinical operations environment, with a strong understanding of ICH-GCP guidelines.
  • Experience with electronic TMFs, naming and filing conventions, and the CDISC TMF Reference Model.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.

What We Offer:

As a TMF Manager at The RFT Group, you will have the opportunity to work with a talented team of professionals in the biotechnology, pharmaceutical, and medical device sectors. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.