TMF Operations Lead

Job Summary

To ensure the completeness and accuracy of TMF documentation for all BBP-418 clinical trials, the remote TMF Operations Lead will develop and implement TMF strategy, oversee compliance with regulatory requirements, and foster cross-functional collaboration.

Key responsibilities

• Lead TMF operations across clinical studies, ensuring timely and inspection-ready documentation in compliance with ICH-GCP and regulatory standards
• Establish TMF governance by monitoring health, quality metrics, and inspection readiness, while communicating findings to study teams and leadership
• Provide strategic oversight of CRO-managed TMF activities and lead inspection readiness efforts, including quality reviews and audit support

Required qualifications

• University degree or comparable professional education in medicine, science, business management, or related fields, or 8+ years of relevant experience
• 8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, particularly with global clinical trials
• Strong knowledge of Trial Master File Reference Model Structure and compliance with ALCOA+ standards and ICH-GCP guidelines
• Proficiency in Microsoft Excel, Word, and PowerPoint; familiarity with Smartsheet and SharePoint is a plus
• Willingness to travel for company meetings and team/study meetings as required