Associate Director, Trial Master File
Structure Therapeutics
14 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
- Strategic oversight, governance, and continuous improvement of the electronic Trial Master File (eTMF) across the clinical trial portfolio; ensures inspection readiness, regulatory compliance, and efficient clinical trial execution.
Job Responsibilities
- Provide strategic leadership and sponsor oversight for the eTMF across all clinical studies.
- Ensure TMF completeness, accuracy, and timeliness throughout the study lifecycle.
- Develop, implement, and maintain TMF governance (SOPs, work instructions, guidance).
- Establish and monitor TMF performance metrics/KPIs; identify trends, risks, and improvements.
- Oversee CRO and vendor TMF activities per contractual/regulatory expectations.
- Serve as TMF subject matter expert for audits and health authority inspections.
- Drive risk-based TMF oversight, issue management, and CAPA development.
- Partner with Clinical Operations, Quality, Regulatory Affairs, and IT.
- Lead/support TMF system implementation, optimization, integration, validation, and change management.
- Develop/deliver TMF training and guidance for internal teams and external partners.
- Ensure documentation of sponsor oversight/decision-making per ICH GCP.
- Support scalability and operational maturity; mentor TMF team/contractors.
Qualifications
- Bachelor’s (or higher) in scientific/health-related discipline; advanced degree preferred.
- 8–10+ years clinical research experience (pharma/biotech/CRO).
- eTMF governance, inspection readiness, and regulatory compliance expertise.
- In-depth ICH GCP (E6 R2/R3) and TMF Reference Model knowledge.
- CRO-heavy/outsourced model experience with sponsor/vendor oversight.
- eTMF systems experience (e.g., Veeva Vault, Trial Interactive, Wingspan) and TMF metrics/KPIs.
Desired Skills & Competencies
- Risk identification/assessment/mitigation; manage TMF issues/deviations/CAPAs.
- Ability to influence without authority; strong stakeholder management.
- Excellent written/verbal communication; executive-level presentation.
- Change management, SOP/governance framework development, and mentoring.
Travel: Up to 20%
Benefits (explicitly mentioned)
- Annual performance incentive bonus; new hire equity and performance-based equity
- Medical, dental, vision; 401k match; unlimited PTO; paid holidays including winter shutdown
Application Instructions
- Apply through the official career page at BambooHR.
- Strategic oversight, governance, and continuous improvement of the electronic Trial Master File (eTMF) across the clinical trial portfolio; ensures inspection readiness, regulatory compliance, and efficient clinical trial execution.
Job Responsibilities
- Provide strategic leadership and sponsor oversight for the eTMF across all clinical studies.
- Ensure TMF completeness, accuracy, and timeliness throughout the study lifecycle.
- Develop, implement, and maintain TMF governance (SOPs, work instructions, guidance).
- Establish and monitor TMF performance metrics/KPIs; identify trends, risks, and improvements.
- Oversee CRO and vendor TMF activities per contractual/regulatory expectations.
- Serve as TMF subject matter expert for audits and health authority inspections.
- Drive risk-based TMF oversight, issue management, and CAPA development.
- Partner with Clinical Operations, Quality, Regulatory Affairs, and IT.
- Lead/support TMF system implementation, optimization, integration, validation, and change management.
- Develop/deliver TMF training and guidance for internal teams and external partners.
- Ensure documentation of sponsor oversight/decision-making per ICH GCP.
- Support scalability and operational maturity; mentor TMF team/contractors.
Qualifications
- Bachelor’s (or higher) in scientific/health-related discipline; advanced degree preferred.
- 8–10+ years clinical research experience (pharma/biotech/CRO).
- eTMF governance, inspection readiness, and regulatory compliance expertise.
- In-depth ICH GCP (E6 R2/R3) and TMF Reference Model knowledge.
- CRO-heavy/outsourced model experience with sponsor/vendor oversight.
- eTMF systems experience (e.g., Veeva Vault, Trial Interactive, Wingspan) and TMF metrics/KPIs.
Desired Skills & Competencies
- Risk identification/assessment/mitigation; manage TMF issues/deviations/CAPAs.
- Ability to influence without authority; strong stakeholder management.
- Excellent written/verbal communication; executive-level presentation.
- Change management, SOP/governance framework development, and mentoring.
Travel: Up to 20%
Benefits (explicitly mentioned)
- Annual performance incentive bonus; new hire equity and performance-based equity
- Medical, dental, vision; 401k match; unlimited PTO; paid holidays including winter shutdown
Application Instructions
- Apply through the official career page at BambooHR.