Trial Master File (TMF) Specialist – Clinical Trials

Pharmaron • Baltimore, MD

9d • $65,000 - $80,000 • Onsite

About The Position

The Trial Master File (TMF) Specialist – Clinical Trials is responsible for the creation, maintenance, and oversight of the sponsor's Trial Master File (TMF) to ensure it is complete, accurate, and inspection-ready at all times. This role serves as a subject matter expert in electronic TMF (eTMF) systems and partners closely with study teams, sponsors, and project management to support clinical trial execution.

Requirements

• Associate's degree with 5+ years of document management experience
• Strong knowledge of Good Clinical Practice (GCP)
• Experience working with electronic TMF (eTMF) systems
• Familiarity with the CDISC TMF Reference Model
• Strong attention to detail and document control skills
• Excellent organizational, communication, and time management skills

Nice To Haves

• Bachelor's degree with 3+ years of TMF or document management experience in a CRO or pharmaceutical environment

Responsibilities

• Serve as the subject matter expert for the electronic TMF (eTMF) platform
• Develop and maintain TMF Plans aligned with study requirements
• Perform ongoing quality control reviews to ensure TMF completeness and accuracy
• Provide regular TMF status and quality reports to sponsors
• Ensure TMFs remain inspection-ready throughout the study lifecycle
• Support study teams during audits, inspections, and sponsor reviews
• Manage TMF access, permissions, and user access logs
• Maintain eTMF change control documentation
• Respond to TMF-related inquiries from sponsors, auditors, and regulatory authorities
• Collaborate with Clinical Research Associates on TMF and Investigator Site File reconciliation
• Participate in study meetings, including Kick-Off and Investigator Meetings, as needed

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees