TMF Lead/Senior TMF Lead

Precision Medicine Group is seeking an experienced TMF Lead or Senior TMF Lead to join our team in a fully remote capacity. You will be responsible for the oversight, management, and delivery of the eTMF in accordance with GCP, ICH guidelines, and regulatory requirements, ensuring all clinical trial documentation remains in an inspection-ready state.

Key responsibilities

• Create and execute study TMF plans and project document indexes while managing team communication.
• Collaborate with Project Managers and functional leads to ensure high-quality, timely submission of TMF documentation.
• Monitor TMF health, identify risks, and implement plans to maintain compliance throughout the study lifecycle.
• Serve as a Subject Matter Expert during audits and inspections and manage study close-out activities.
• Support process development initiatives and mentor junior team members within the Records Management department.

Requirements

• 4-year college degree or equivalent combination of education and experience in a business, scientific, or healthcare discipline.
• At least 3 to 4 years of experience with TMF/eTMF, including a minimum of 1 year as a TMF Lead.
• Professional proficiency in English and strong skills in the Microsoft Office suite.
• Ideally, experience using Veeva Vault for document processing.
• Strong interpersonal skills, detail-oriented mindset, and the ability to work independently.

What we offer

• Fully remote work environment.
• Discretionary annual bonus.
• Private medical insurance and life insurance.
• Home working allowance and additional benefits.