Senior TMF Specialist
Dyne Therapeutics
6 hours ago
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Role Summary
The Senior TMF Specialist supports the ongoing maintenance, quality, and inspection readiness of the Trial Master File (TMF) across assigned clinical studies. Ensures TMF integrity, completeness, and compliance, including accurate filing, tracking, and quality control of TMF documents in accordance with ICH-GCP, the TMF Reference Model, and company procedures. Partners with Clinical Operations, Quality, Regulatory, and external partners to ensure timely document collection and an inspection-ready TMF.
Location: Waltham, MA
Primary Responsibilities
- Participate in creation, maintenance, and management of TMF for clinical studies (e.g., ICH/FDA compliance and internal policies)
- Develop and implement TMF processes/procedures for timely, accurate trial documentation
- Support day-to-day TMF activities: filing, indexing, and quality control in the eTMF
- Ensure accurate, complete, and timely TMF filing per SOPs, TMF Reference Model, and regulatory requirements
- Perform routine TMF completeness/quality checks; identify missing/incorrect/misfiled documents
- Track document deliverables and follow up with study teams, CROs, and vendors to resolve gaps
- Support TMF health assessments and inspection readiness
- Assist with audit/inspection preparation (document reconciliation and retrieval), identify gaps, and implement corrective actions
- Document TMF issues/deviations/quality observations and support corrective actions
- Serve as contact for TMF-related queries during regulatory inspections/audits
- Adhere to TMF processes/SOPs/work instructions; identify and escalate process improvement opportunities
- Support TMF process updates, system enhancements, and user acceptance testing
- Support onboarding/training for internal teams and vendors on TMF processes and eTMF usage; maintain TMF trackers/logs
- Oversee TMF service providers, CRO partners, and technology platforms; ensure vendor adherence to TMF-related contractual/quality expectations
- Collaborate cross-functionally (Clinical Operations, Quality, Regulatory, external partners); serve as TMF point of contact for assigned studies
Education & Qualifications
- Bachelor’s degree in life sciences (or related field)
- 6+ years of experience in clinical operations, TMF/document management, or a regulated GxP environment
Required Skills/Knowledge
- Strong knowledge of TMF regulatory requirements and guidelines (ICH-GCP, TMF Reference Model, clinical trial documentation)
- Proven hands-on experience with eTMF systems, document management software, and document quality control
- Experience working with eTMF systems and CRO/vendor oversight
- Excellent organizational skills; ability to work independently and collaboratively in a fast-paced environment
- Excellent written/verbal communication, influencing, and stakeholder management skills
- Ability to interact effectively with cross-functional and external stakeholders at all levels
- Ability to manage multiple complex programs in dynamic, fast-paced settings
- Strategic thinking; balance scientific, regulatory, and business considerations
- Demonstrated ability to influence stakeholders without direct authority
- Meticulous attention to detail with commitment to quality and compliance
- Positive, proactive, resilient team mindset aligned to core values
- Ability to drive timelines, meet deadlines, and adapt to changing priorities
Compensation (if applicable)
- MA Pay Range: $155,000 - $190,000 USD
The Senior TMF Specialist supports the ongoing maintenance, quality, and inspection readiness of the Trial Master File (TMF) across assigned clinical studies. Ensures TMF integrity, completeness, and compliance, including accurate filing, tracking, and quality control of TMF documents in accordance with ICH-GCP, the TMF Reference Model, and company procedures. Partners with Clinical Operations, Quality, Regulatory, and external partners to ensure timely document collection and an inspection-ready TMF.
Location: Waltham, MA
Primary Responsibilities
- Participate in creation, maintenance, and management of TMF for clinical studies (e.g., ICH/FDA compliance and internal policies)
- Develop and implement TMF processes/procedures for timely, accurate trial documentation
- Support day-to-day TMF activities: filing, indexing, and quality control in the eTMF
- Ensure accurate, complete, and timely TMF filing per SOPs, TMF Reference Model, and regulatory requirements
- Perform routine TMF completeness/quality checks; identify missing/incorrect/misfiled documents
- Track document deliverables and follow up with study teams, CROs, and vendors to resolve gaps
- Support TMF health assessments and inspection readiness
- Assist with audit/inspection preparation (document reconciliation and retrieval), identify gaps, and implement corrective actions
- Document TMF issues/deviations/quality observations and support corrective actions
- Serve as contact for TMF-related queries during regulatory inspections/audits
- Adhere to TMF processes/SOPs/work instructions; identify and escalate process improvement opportunities
- Support TMF process updates, system enhancements, and user acceptance testing
- Support onboarding/training for internal teams and vendors on TMF processes and eTMF usage; maintain TMF trackers/logs
- Oversee TMF service providers, CRO partners, and technology platforms; ensure vendor adherence to TMF-related contractual/quality expectations
- Collaborate cross-functionally (Clinical Operations, Quality, Regulatory, external partners); serve as TMF point of contact for assigned studies
Education & Qualifications
- Bachelor’s degree in life sciences (or related field)
- 6+ years of experience in clinical operations, TMF/document management, or a regulated GxP environment
Required Skills/Knowledge
- Strong knowledge of TMF regulatory requirements and guidelines (ICH-GCP, TMF Reference Model, clinical trial documentation)
- Proven hands-on experience with eTMF systems, document management software, and document quality control
- Experience working with eTMF systems and CRO/vendor oversight
- Excellent organizational skills; ability to work independently and collaboratively in a fast-paced environment
- Excellent written/verbal communication, influencing, and stakeholder management skills
- Ability to interact effectively with cross-functional and external stakeholders at all levels
- Ability to manage multiple complex programs in dynamic, fast-paced settings
- Strategic thinking; balance scientific, regulatory, and business considerations
- Demonstrated ability to influence stakeholders without direct authority
- Meticulous attention to detail with commitment to quality and compliance
- Positive, proactive, resilient team mindset aligned to core values
- Ability to drive timelines, meet deadlines, and adapt to changing priorities
Compensation (if applicable)
- MA Pay Range: $155,000 - $190,000 USD