Trial Master File Specialist

Overview

The TMF Specialist is a member of Clinical Operations and serves as the sponsor’s Trial Master File subject matter expert. This role provides proactive, end-to-end TMF ownership and oversight across clinical studies, from study start-up and TMF establishment through study conduct, closeout, final reconciliation, transfer, and archival.

The position is responsible and accountable for ensuring that sponsor- and CRO-managed TMFs are complete, accurate, timely, inspection ready, and maintained in accordance with applicable regulations, ICH GCP, internal SOPs, study-specific TMF plans, and company quality standards. The role identifies gaps, establishes corrective actions, follows issues through documented resolution, and escalates significant or persistent deficiencies when necessary.

Responsibilities

• Serve as the primary Clinical Operations TMF subject matter expert and central point of contact for TMF activities across all assigned clinical studies.
• Provide end-to-end ownership and sponsor oversight of the TMF lifecycle, from study start-up through study conduct, closeout, finalization, and archival.
• Establish and review study-specific TMF plans, filing structures, document expectations, ownership, timelines, quality requirements, and escalation pathways at study initiation.
• Oversee CRO and vendor TMF activities for compliance with contractual requirements, TMF plans, SOPs, quality standards, and applicable regulations.
• Conduct routine and risk-based reviews to assess TMF completeness, accuracy, quality, timeliness, and appropriate filing of essential documents.
• Identify missing, incomplete, late, duplicate, incorrectly filed, or otherwise deficient documents and establish specific remediation actions, owners, and due dates.
• Maintain TMF action-item trackers, issue logs, metrics, dashboards, and remediation plans; follow each issue through documented closure.
• Hold CROs, vendors, and internal Clinical Operations study team members accountable for timely resolution of findings and escalate persistent or significant issues to Clinical Operations leadership.
• Partner with Clinical Trial and Study Managers to manage TMF activities and reduce their administrative TMF burden, enabling greater focus on study management, site performance, timelines, and CRO oversight.
• Establish and facilitate periodic TMF review meetings with Clinical Operations, CROs, vendors, and relevant functional stakeholders.
• Monitor TMF health and identify trends, recurring deficiencies, overdue documentation, and areas requiring corrective or preventive action.
• Develop and implement TMF quality and inspection-readiness strategies throughout each study lifecycle.
• Ensure the TMF provides a clear, complete, and contemporaneous record of trial conduct and sponsor oversight.
• Perform or coordinate reconciliation of the TMF with relevant systems, trackers, vendor records, and study documentation.
• Support study closeout by ensuring required essential documents are collected, reviewed, reconciled, and appropriately filed before TMF finalization.
• Coordinate final TMF quality review, reconciliation, transfer, acceptance, finalization, and archival activities.
• Ensure outstanding TMF issues are appropriately resolved or formally documented before final TMF acceptance.
• Support audits, regulatory inspections, and internal quality reviews by maintaining inspection readiness and facilitating timely retrieval of requested documentation.
• Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, Clinical Development, Data Management, Safety, and other functions to meet cross-functional TMF requirements.
• Contribute to the development and continuous improvement of TMF-related SOPs, work instructions, templates, processes, and training.

Provide TMF training, coaching, and guidance to Clinical Operations personnel and other study team members.

Apply lessons learned from ongoing and completed studies to strengthen TMF processes, quality, and sponsor oversight across future studies.

Qualifications

The TMF Coordinator or TMF Specialist is accountable for proactive sponsor-level TMF oversight throughout the entire clinical trial lifecycle. The role identifies issues early, assigns clear actions and owners, tracks commitments, escalates when necessary, and ensures that issues reach appropriate and documented resolution.

This is not solely a document-filing or administrative support position. It is an oversight, quality, compliance, and inspection-readiness role within Clinical Operations that strengthens sponsor control and visibility while allowing Clinical Trial and Study Managers to focus on broader study management responsibilities.

• Bachelor’s degree in life sciences, healthcare, or a related discipline preferred.
• 3-5+ years of Clinical Operations and/or Trial Master File experience in a pharmaceutical, biotechnology, or CRO environment.
• Strong working knowledge of TMF principles, essential documents, clinical trial processes, and ICH GCP requirements.
• Experience with electronic TMF systems and CRO-managed TMFs.
• Demonstrated ability to identify TMF quality issues, establish corrective actions, and drive issues through resolution.
• Strong organizational, follow-up, communication, and cross-functional collaboration skills.
• Ability to challenge and hold CROs, vendors, and internal stakeholders accountable while maintaining productive working relationships.
• Clear understanding of sponsor oversight responsibilities and inspection-readiness expectations.

Compensation & Benefits

The anticipated salary range for this position is $70,000 to $85,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.

In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.