TMF Lead/Senior TMF Lead

Precision for Medicine is seeking an experienced TMF Lead or Senior TMF Lead to join our team. In this fully remote role, you will be responsible for the oversight, management, and delivery of the eTMF in accordance with Good Clinical Practice (GCP) and relevant regulatory guidelines, ensuring all documentation remains in an inspection-ready state.

Key responsibilities

• Create and execute study TMF plans and project document indexes while ensuring the team understands all project-specific requirements.
• Collaborate with Project Managers and functional leads to ensure high-quality, timely documentation and identify early signals of risk.
• Monitor and report on TMF health, identifying trends and managing compliance checks throughout the study lifecycle.
• Serve as a Subject Matter Expert during audits or inspections and support the development of TMF-related processes.
• Manage study close-out activities, including final document processing and transfers to sponsors.

Requirements

• Four-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 in a TMF Lead capacity.
• Proficiency in Microsoft Office programs and strong verbal and written communication skills in English.
• Ideally, experience using Veeva Vault to process clinical documents.
• Ability to work independently, manage competing priorities, and maintain high attention to detail.

What we offer

• Opportunity to work in a fully remote environment within a global organization.
• Access to private medical insurance and life insurance coverage.
• Participation in a discretionary annual bonus program.
• Home working allowance and additional benefits such as a pension scheme and vacation time.