Associate Director, TMF Operations Lead
Benefits
Unlimited PTO
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Responsibilities:
- Lead TMF operations across clinical studies ensuring documentation is timely, complete, and inspection-ready.
- Establish TMF governance and monitor quality metrics, communicating findings to study teams.
- Develop and improve TMF processes including plans, indexes, SOPs, and oversight documents.
Qualifications:
- 8+ years in TMF Operations, Clinical Operations, or Clinical Quality.
- Strong knowledge of TMF Reference Model, ALCOA+, and ICH-GCP.
- Proficient in Microsoft Excel, Word, PowerPoint, Smartsheet, and SharePoint.
Benefits:
- Market-leading compensation with 401(k) match and ESPP.
- 100% employer-paid medical, dental, and vision premiums.
- Flexible, take-what-you-need paid time off and comprehensive parental leave.
BridgeBio
BridgeBio pioneers a 'moneyball for biotech' approach, pooling early-stage research to reduce risk and accelerate innovation for life-changing medicines. They foster a culture of curiosity and experimentation with a focus on ethics.