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
TMF Operations Lead • Fort Worth, Texas, United States
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