Senior TMF Specialist
Dyne Therapeutics, Waltham, MA, United States
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. We are advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) and have preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
Role Summary:
The Senior TMF Specialist supports ongoing maintenance, quality, and inspection readiness of the Trial Master File (TMF) across assigned clinical studies. This role ensures integrity, completeness, and compliance of our TMF, including accurate filing, tracking, and quality control of documents per ICH‑GCP, TMF Reference Model, and company procedures. It requires deep knowledge of regulatory requirements and partners closely with Clinical Operations, Quality, Regulatory, and external partners to keep the TMF inspection‑ready.
Location: Waltham, MA.
Responsibilities
Participate in the creation, maintenance, and management of the TMF for clinical studies, ensuring compliance with ICH, FDA, and internal policies.
Develop and implement TMF‑related processes and procedures to ensure timely and accurate documentation of all trial‑related activities.
Support day‑to‑day TMF activities for assigned studies, including filing, indexing, and quality control of documents within the eTMF system.
Perform routine TMF completeness and quality checks, identifying missing, incorrect, or misfiled documents.
Track document deliverables and follow up with study teams, CROs, and vendors to resolve gaps.
Support TMF health assessments, inspection readiness activities, audit and inspection preparation, and document reconciliation.
Document TMF issues, deviations, or quality observations and support corrective actions.
Participate in TMF inspections and audits by regulatory authorities and serve as a contact for TMF‑related queries.
Adhere to company TMF processes, SOPs, and work instructions.
Identify opportunities for process improvement, standardization, or increased efficiency and recommend changes.
Support TMF process updates, system enhancements, and user acceptance testing.
Support onboarding and training of internal team members and vendors on TMF processes, eTMF usage, and best practices.
Maintain TMF‑related trackers, logs, and study documentation as required.
Stay current with industry trends and regulatory changes impacting TMF management.
Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements.
Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF.
Collaborate with Clinical Operations, Quality, Regulatory, and external partners to support TMF expectations and timelines.
Serve as a TMF point of contact for assigned studies, answering procedural and process‑related questions.
Education and Skills Requirements
Bachelor’s degree in life sciences or a related field.
6+ years of experience in clinical operations, TMF management, document management, or a regulated GxP environment.
Strong knowledge of regulatory requirements and guidelines governing TMF maintenance and management, ICH‑GCP, TMF Reference Model, and clinical trial documentation requirements.
Proven hands‑on experience with eTMF systems, document management software, and document quality control.
Excellent organizational skills and ability to work independently as well as collaboratively in a fast‑paced environment.
Experience working with eTMF systems and CRO/vendor oversight.
Excellent communication (written and verbal), influencing, and stakeholder management skills.
Ability to interact effectively with cross‑functional teams and external stakeholders at all levels.
Proven ability to independently manage multiple complex programs in a fast‑paced, dynamic environment.
Strong strategic thinking skills with ability to balance scientific, regulatory, and business considerations.
Demonstrated ability to influence cross‑functional stakeholders without direct authority.
Highly collaborative team player with a strong cross‑functional mindset.
Meticulous attention to detail with a commitment to quality and compliance.
Positive, proactive, and resilient team member who embodies Dyne’s core values.
Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases.
Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities.
Compensation MA Pay Range: $155,000 - $190,000 USD. The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job‑related knowledge, and demonstrated skills.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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Role Summary:
The Senior TMF Specialist supports ongoing maintenance, quality, and inspection readiness of the Trial Master File (TMF) across assigned clinical studies. This role ensures integrity, completeness, and compliance of our TMF, including accurate filing, tracking, and quality control of documents per ICH‑GCP, TMF Reference Model, and company procedures. It requires deep knowledge of regulatory requirements and partners closely with Clinical Operations, Quality, Regulatory, and external partners to keep the TMF inspection‑ready.
Location: Waltham, MA.
Responsibilities
Participate in the creation, maintenance, and management of the TMF for clinical studies, ensuring compliance with ICH, FDA, and internal policies.
Develop and implement TMF‑related processes and procedures to ensure timely and accurate documentation of all trial‑related activities.
Support day‑to‑day TMF activities for assigned studies, including filing, indexing, and quality control of documents within the eTMF system.
Perform routine TMF completeness and quality checks, identifying missing, incorrect, or misfiled documents.
Track document deliverables and follow up with study teams, CROs, and vendors to resolve gaps.
Support TMF health assessments, inspection readiness activities, audit and inspection preparation, and document reconciliation.
Document TMF issues, deviations, or quality observations and support corrective actions.
Participate in TMF inspections and audits by regulatory authorities and serve as a contact for TMF‑related queries.
Adhere to company TMF processes, SOPs, and work instructions.
Identify opportunities for process improvement, standardization, or increased efficiency and recommend changes.
Support TMF process updates, system enhancements, and user acceptance testing.
Support onboarding and training of internal team members and vendors on TMF processes, eTMF usage, and best practices.
Maintain TMF‑related trackers, logs, and study documentation as required.
Stay current with industry trends and regulatory changes impacting TMF management.
Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements.
Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF.
Collaborate with Clinical Operations, Quality, Regulatory, and external partners to support TMF expectations and timelines.
Serve as a TMF point of contact for assigned studies, answering procedural and process‑related questions.
Education and Skills Requirements
Bachelor’s degree in life sciences or a related field.
6+ years of experience in clinical operations, TMF management, document management, or a regulated GxP environment.
Strong knowledge of regulatory requirements and guidelines governing TMF maintenance and management, ICH‑GCP, TMF Reference Model, and clinical trial documentation requirements.
Proven hands‑on experience with eTMF systems, document management software, and document quality control.
Excellent organizational skills and ability to work independently as well as collaboratively in a fast‑paced environment.
Experience working with eTMF systems and CRO/vendor oversight.
Excellent communication (written and verbal), influencing, and stakeholder management skills.
Ability to interact effectively with cross‑functional teams and external stakeholders at all levels.
Proven ability to independently manage multiple complex programs in a fast‑paced, dynamic environment.
Strong strategic thinking skills with ability to balance scientific, regulatory, and business considerations.
Demonstrated ability to influence cross‑functional stakeholders without direct authority.
Highly collaborative team player with a strong cross‑functional mindset.
Meticulous attention to detail with a commitment to quality and compliance.
Positive, proactive, and resilient team member who embodies Dyne’s core values.
Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases.
Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities.
Compensation MA Pay Range: $155,000 - $190,000 USD. The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job‑related knowledge, and demonstrated skills.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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