Associate Director, TMF Operations Lead
New
B
BridgeBioBiopharmaceutical
Remote - USAFull-TimeSenior
Salary$191,000 — $220,000 USD
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Job Details
- Experience
- 8+ years
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- 8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality.
- Experience supporting global clinical trials.
- Strong knowledge of Trial Master File Reference Model Structure and country-level documents.
- Demonstrated ability to comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices.
- Understanding of the drug development life cycle.
- University degree in medicine, science, paramedical science, computer science, business management, or equivalent experience.
- Proficiency in Microsoft Excel, Word, and PowerPoint.
- Familiarity with Smartsheet and SharePoint.
- Strong verbal and written communication skills.
- Must be willing to travel for company meetings for a minimum of one week per quarter.
Responsibilities
- Lead TMF operations across assigned clinical studies, ensuring timely, complete, and inspection-ready documentation.
- Establish TMF governance by monitoring health, quality metrics, risk assessments, and inspection readiness.
- Develop and improve TMF processes, including plans, indexes, SOPs, and oversight plans.
- Partner with Clinical Operations, Regulatory, Data Management, and vendors to ensure consistent execution.
- Provide strategic oversight of CRO-managed TMF activities through performance metrics and quality reviews.
- Lead inspection readiness activities, including audit support, preparation, and CAPA development.
- Serve as the TMF Subject Matter Expert to provide guidance, training, and mentorship.
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