Associate Director / Director, Study Trial Master File

Larimar Therapeutics • Lower Merion Township, PA

110d

About The Position

We are seeking an experienced and detail-oriented Associate Director or Director to lead all aspects of Trial Master File (TMF) management for a single, global clinical trial. This TMF Owner will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF for a global study, ensuring it remains inspection-ready throughout the study lifecycle. This is a hands-on leadership role that requires deep expertise in TMF operations, global regulatory standards, and cross-functional collaboration. The successful candidate will be a strong leader with excellent communication and collaboration skills, preferably with 10-15 years’ experience in managing clinical TMFs across the US and EU, and significant vendor management experience. This role will require a minimum of 2 days a week of onsite presence (or more as business needs require) in our Bala Cynwyd, PA corporate office.

Requirements

• Minimum of 15+ years of relevant industry experience with a Bachelor’s degree, or 10+ years with a postgraduate degree.
• Experience managing TMF for global clinical trials including direct vendor oversight.
• Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms.
• Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and well-versed in industry best practices for Trial Master File (TMF) operations.
• Strong, practical knowledge of the DIA TMF Reference Model and its application within operational settings.
• Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities.
• Exceptional communication skills—able to clearly convey complex information to diverse stakeholders and foster collaboration across cross-functional teams.
• Highly skilled in project management, with the ability to oversee multiple concurrent initiatives, establish priorities, and consistently meet critical deadlines.
• Recognized for strategic problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment.
• Ability and willingness to work onsite at least two days per week, while maintaining strong collaboration in a hybrid work model.

Responsibilities

• Serve as the TMF lead for a global clinical trial, fully accountable for the accuracy, consistency, completeness, and regulatory compliance of the Trial Master File from study start-up through final archival.
• Develop, update, and deliver TMF processes, procedures, and training in alignment with industry best practices and evolving regulatory requirements.
• Lead the TMF plan and build study eTMF and ensure completeness accordingly.
• Ensure TMF documentation is consistent with specifications, internal SOPs, and applicable regulatory guidelines (ICH GCP, FDA, EMA, and other country-specific requirements).
• Maintain TMF inspection- and submission-readiness throughout the trial lifecycle, monitoring quality and implementing corrective actions when necessary.
• Act as the primary point of contact for all TMF-related activities, queries, and decisions for the trial.
• Stay current with regulatory changes and industry best practices, translating them into actionable process improvements.
• Conduct ongoing quality control reviews of TMF content to ensure accuracy, timeliness, and compliance.
• Establish and monitor TMF performance metrics, monitoring them, and proactively identifying and addressing documentation gaps.
• Drive continuous improvement in TMF operations, including CAPAs and lessons learned.
• Travel domestically and internationally (~10%) for vendor oversight, study team meetings, audits, or inspections.
• Work closely with clinical operations, regulatory affairs, quality assurance, and other internal stakeholders to support timely and accurate documentation filing.
• Lead TMF-related communications with study teams, ensuring alignment on responsibilities, timelines, and expectations.
• Support inspection readiness activities, including internal reviews, mock inspections, and audit preparation.
• Manage and build strong partnerships with external vendors, CROs, and internal stakeholders to ensure consistent TMF standards, timely document flow, and adherence to project milestones.
• Manage third-party TMF vendor(s) involved in the trial, ensuring adherence to quality standards, timelines, and deliverables.
• Serve as the business owner of the eTMF system for the study, including oversight of configuration, access controls, and change management.
• Oversee records management for the trial, including off-site storage and archival, ensuring compliant chain-of-custody practices.
• Ensure the TMF is prepared for regulatory inspection at any point during the trial.
• Lead TMF reviews and remediation efforts in preparation for audits or inspections.
• Assist with audit response and CAPA development as needed.
• Perform related duties as necessary or as assigned.

Benefits

• Competitive salary with frequent market benchmarking.
• Incentive stock options.
• Comprehensive benefits plan including 401K.
• Flexible PTO policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees