Trial Master File Sr. Manager, Clinical Operations
Maze Therapeutics
August 14, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Responsibilities:
- Lead the transition of Trial Master File (TMF) management from outsourced to in-house, including eTMF platform evaluation/implementation with IT.
- Develop and maintain TMF governance, SOPs/work instructions, filing standards, taxonomy/indexing, and document management workflows.
- Serve as primary TMF SME for early phase, Phase 2, and Phase 3 programs; develop study-specific TMF plans and document oversight strategies.
- Ensure TMF documents are complete, accurate, and filed on time throughout the study lifecycle.
- Monitor TMF health via routine completeness/timeliness/quality reviews; resolve document gaps.
- Partner with Quality Assurance to drive continuous inspection readiness, lead TMF quality reviews, and support internal/sponsor/regulatory inspections.
- Ensure compliance with ICH-GCP and applicable regulatory requirements (including FDA/EMA) and ALCOA+ principles.
- Develop TMF KPIs/dashboards, improve processes/technology/efficiency, and champion continuous improvement (including AI-enabled solutions).
Qualifications:
- Bachelor’s degree in Life Sciences, Healthcare Administration, or related field.
- 6–8+ years in Clinical Operations/Clinical Trial Management/TMF management (biotech/pharma/CRO).
- 4–5+ years dedicated experience managing eTMFs across multiple global studies.
- Experience supporting early phase, Phase 2, and Phase 3 trials in a GCP-regulated environment.
- Proven experience leading TMF inspection readiness and partnering with QA for audits/inspections.
- Experience developing TMF governance, SOPs, filing standards, and quality management practices.
- Hands-on experience with eTMF platforms (e.g., Veeva Vault eTMF, Trial Interactive) and strong ICH-GCP/FDA/EMA/ALCOA+ knowledge.
- Preferred: AI-enabled solution experience for TMF quality/inspection readiness and dashboard/KPI reporting experience.
Benefits:
- Expected annual salary (San Francisco Bay Area): $175,000–$215,000; eligible for annual performance bonus.
- Medical, dental, and vision insurance; mental health offerings; equity incentive plan; 401(k) match; generous holiday and PTO.
- Lead the transition of Trial Master File (TMF) management from outsourced to in-house, including eTMF platform evaluation/implementation with IT.
- Develop and maintain TMF governance, SOPs/work instructions, filing standards, taxonomy/indexing, and document management workflows.
- Serve as primary TMF SME for early phase, Phase 2, and Phase 3 programs; develop study-specific TMF plans and document oversight strategies.
- Ensure TMF documents are complete, accurate, and filed on time throughout the study lifecycle.
- Monitor TMF health via routine completeness/timeliness/quality reviews; resolve document gaps.
- Partner with Quality Assurance to drive continuous inspection readiness, lead TMF quality reviews, and support internal/sponsor/regulatory inspections.
- Ensure compliance with ICH-GCP and applicable regulatory requirements (including FDA/EMA) and ALCOA+ principles.
- Develop TMF KPIs/dashboards, improve processes/technology/efficiency, and champion continuous improvement (including AI-enabled solutions).
Qualifications:
- Bachelor’s degree in Life Sciences, Healthcare Administration, or related field.
- 6–8+ years in Clinical Operations/Clinical Trial Management/TMF management (biotech/pharma/CRO).
- 4–5+ years dedicated experience managing eTMFs across multiple global studies.
- Experience supporting early phase, Phase 2, and Phase 3 trials in a GCP-regulated environment.
- Proven experience leading TMF inspection readiness and partnering with QA for audits/inspections.
- Experience developing TMF governance, SOPs, filing standards, and quality management practices.
- Hands-on experience with eTMF platforms (e.g., Veeva Vault eTMF, Trial Interactive) and strong ICH-GCP/FDA/EMA/ALCOA+ knowledge.
- Preferred: AI-enabled solution experience for TMF quality/inspection readiness and dashboard/KPI reporting experience.
Benefits:
- Expected annual salary (San Francisco Bay Area): $175,000–$215,000; eligible for annual performance bonus.
- Medical, dental, and vision insurance; mental health offerings; equity incentive plan; 401(k) match; generous holiday and PTO.