Associate Director, TMF Operations
Candel Therapeutics
10 days ago
Remote friendly (Needham, MA)
United States
Clinical Research and Development
Position Summary
We’re looking for an experienced Associate Director, Trial Master File (TMF) Operations to lead TMF operations across oncology clinical programs.
What You’ll Do
- Lead TMF operational strategy and build scalable, inspection-ready processes across studies.
- Oversee electronic TMF activities to ensure quality, completeness, accuracy, and regulatory compliance.
- Develop TMF standards, governance models, workflows, and procedural documentation aligned with best practices and global regulations.
- Serve as TMF subject matter expert and strategic partner to Clinical Operations and cross-functional stakeholders.
- Manage the eTMF system vendor.
- Establish TMF health metrics, dashboards, and operational KPIs.
- Conduct TMF reviews, quality assessments, and operational audits for inspection readiness.
- Partner with CROs and vendors to ensure deliverables, timelines, and performance standards.
- Support implementation/optimization/integration of TMF-related systems (e.g., eTMF platforms, CTMS, EDC).
- Collaborate with IT on enhancements, upgrades, validation, and change management.
- Improve workflows and drive operational excellence.
- Train/guidance internal teams on TMF processes and best practices.
- Support clinical trial disclosure and registry compliance.
What You Bring
- Bachelor’s degree in a scientific/healthcare field (or equivalent experience).
- 10+ years clinical research experience in biotech/pharma/CRO.
- Strong TMF operations, document management, and inspection readiness experience.
- Hands-on eTMF system and TMF reporting experience.
- Deep knowledge of ICH-GCP, TMF best practices, and global regulations.
- Matrixed collaboration experience with CROs/vendors.
- Excellent organizational, communication, and problem-solving skills; proactive and able to work independently.
Work Environment
- Hybrid (Needham, MA); ~2–3 days/week onsite; occasional travel.
Application Instructions
- Must be authorized to work in the US (no sponsorship). No agencies.
We’re looking for an experienced Associate Director, Trial Master File (TMF) Operations to lead TMF operations across oncology clinical programs.
What You’ll Do
- Lead TMF operational strategy and build scalable, inspection-ready processes across studies.
- Oversee electronic TMF activities to ensure quality, completeness, accuracy, and regulatory compliance.
- Develop TMF standards, governance models, workflows, and procedural documentation aligned with best practices and global regulations.
- Serve as TMF subject matter expert and strategic partner to Clinical Operations and cross-functional stakeholders.
- Manage the eTMF system vendor.
- Establish TMF health metrics, dashboards, and operational KPIs.
- Conduct TMF reviews, quality assessments, and operational audits for inspection readiness.
- Partner with CROs and vendors to ensure deliverables, timelines, and performance standards.
- Support implementation/optimization/integration of TMF-related systems (e.g., eTMF platforms, CTMS, EDC).
- Collaborate with IT on enhancements, upgrades, validation, and change management.
- Improve workflows and drive operational excellence.
- Train/guidance internal teams on TMF processes and best practices.
- Support clinical trial disclosure and registry compliance.
What You Bring
- Bachelor’s degree in a scientific/healthcare field (or equivalent experience).
- 10+ years clinical research experience in biotech/pharma/CRO.
- Strong TMF operations, document management, and inspection readiness experience.
- Hands-on eTMF system and TMF reporting experience.
- Deep knowledge of ICH-GCP, TMF best practices, and global regulations.
- Matrixed collaboration experience with CROs/vendors.
- Excellent organizational, communication, and problem-solving skills; proactive and able to work independently.
Work Environment
- Hybrid (Needham, MA); ~2–3 days/week onsite; occasional travel.
Application Instructions
- Must be authorized to work in the US (no sponsorship). No agencies.