Trial Master File (TMF) Specialist - Clinical Trials

Location: Pharmaron Baltimore Campus, Baltimore

Compensation: $65-80K Annually

About Pharmaron

Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programs, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit .

Position Summary

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.

Key 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

Qualifications

Required

• 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

Preferred

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

Work Environment

• Office-based, temperature-controlled environment
• Minimal to no travel required

Physical Requirements

• Primarily sedentary work with frequent computer use
• Ability to perform repetitive hand and finger movements
• Occasional light lifting (up to 20 lbs)

Position Details

• Type: Full-time
• FLSA: Exempt

Unfortunately, we cannot support work visa permit applications for this role

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• 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

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.