Associate Director, TMF Operations Lead
BridgeBio
August 15, 2026
Remote friendly (United States)
United States
Operations
TMF Operations Lead (BBP-418)
Responsibilities:
- Lead TMF operations across assigned clinical studies; ensure timely, complete, inspection-ready Trial Master File (TMF) documentation in line with ICH-GCP, regulatory requirements, and company standards.
- Establish TMF governance by monitoring TMF health, quality metrics, risk assessments, and inspection readiness; communicate findings to study teams and leadership.
- Develop/maintain/improve TMF processes and governing documents (TMF Plans, TMF Indexes, SOPs, guidance, and CRO TMF Oversight Plans).
- Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure timely filing, issue resolution, and consistent TMF execution.
- Provide strategic oversight of CRO-managed TMF activities (metrics, governance meetings, quality reviews, escalation, continuous improvement).
- Lead inspection readiness (quality reviews, health assessments, audit/inspection support, artifact retrieval, CAPA development/follow-up).
- Identify TMF compliance risks/trends; drive corrective and preventive actions for continuous inspection readiness.
- Serve as TMF SME: guidance, training, mentoring, and cross-functional representation.
- Analyze TMF performance and vendor quality outputs; recommend improvements and enhance operational effectiveness.
Qualifications & Skills:
- Education: University degree (preferably medicine/science/paramedical science/computer science/business management or related) or >8 years equivalent experience.
- Experience: 8+ years in TMF Operations, Clinical Operations, or Clinical Quality; experience supporting global clinical trials.
- Drug development life cycle knowledge; experience handling clinical trial-related documents.
- Strong TMF Reference Model Structure and country-level document knowledge.
- Ability to comply with ALCOA+, ICH-GCP, and Good Documentation Practices.
- Strong organization, attention to detail, communication (verbal/written), and initiative.
- Proficient in Microsoft Excel/Word/PowerPoint; familiar with Smartsheet and SharePoint.
- Travel: remote candidates must travel at least one week per quarter.
Compensation (California): $191,000–$220,000 USD.
Responsibilities:
- Lead TMF operations across assigned clinical studies; ensure timely, complete, inspection-ready Trial Master File (TMF) documentation in line with ICH-GCP, regulatory requirements, and company standards.
- Establish TMF governance by monitoring TMF health, quality metrics, risk assessments, and inspection readiness; communicate findings to study teams and leadership.
- Develop/maintain/improve TMF processes and governing documents (TMF Plans, TMF Indexes, SOPs, guidance, and CRO TMF Oversight Plans).
- Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure timely filing, issue resolution, and consistent TMF execution.
- Provide strategic oversight of CRO-managed TMF activities (metrics, governance meetings, quality reviews, escalation, continuous improvement).
- Lead inspection readiness (quality reviews, health assessments, audit/inspection support, artifact retrieval, CAPA development/follow-up).
- Identify TMF compliance risks/trends; drive corrective and preventive actions for continuous inspection readiness.
- Serve as TMF SME: guidance, training, mentoring, and cross-functional representation.
- Analyze TMF performance and vendor quality outputs; recommend improvements and enhance operational effectiveness.
Qualifications & Skills:
- Education: University degree (preferably medicine/science/paramedical science/computer science/business management or related) or >8 years equivalent experience.
- Experience: 8+ years in TMF Operations, Clinical Operations, or Clinical Quality; experience supporting global clinical trials.
- Drug development life cycle knowledge; experience handling clinical trial-related documents.
- Strong TMF Reference Model Structure and country-level document knowledge.
- Ability to comply with ALCOA+, ICH-GCP, and Good Documentation Practices.
- Strong organization, attention to detail, communication (verbal/written), and initiative.
- Proficient in Microsoft Excel/Word/PowerPoint; familiar with Smartsheet and SharePoint.
- Travel: remote candidates must travel at least one week per quarter.
Compensation (California): $191,000–$220,000 USD.