Trial Master File Specialist

Pharmaron • Baltimore, MD

12d • $65,000 - $80,000 • Onsite

About The Position

In this role, you will play a critical part in ensuring TMFs remain compliant, complete, and inspection-ready while supporting the successful execution of clinical trials.

Requirements

• Associate's degree and 5+ years of TMF, clinical document management, clinical operations, or regulatory experience within a CRO, biotechnology, or pharmaceutical environment, OR Bachelor's degree and 3+ years of TMF or clinical document management experience within a CRO, biotechnology, or pharmaceutical environment.
• Proficiency with Microsoft office including outlook, MS-word, excel, etc.
• Hands-on experience managing electronic Trial Master Files (eTMFs).
• Strong understanding of ICH-GCP guidelines and clinical trial regulatory requirements.
• Familiarity with the CDISC TMF Reference Model.
• Experience performing TMF quality reviews, reconciliation activities, and inspection readiness support.
• Ability to manage multiple studies and competing priorities in a fast-paced environment.
• Excellent organizational, communication, and problem-solving skills.
• Strong attention to detail and commitment to quality.

Responsibilities

• Own and manage sponsor Trial Master Files (TMFs) from study start-up through closeout.
• Develop and maintain TMF Plans and filing strategies.
• Serve as the subject matter expert for electronic TMF (eTMF) systems and processes.
• Ensure TMFs are maintained in accordance with ICH-GCP, regulatory requirements, and the CDISC TMF Reference Model.
• Conduct ongoing TMF quality reviews to ensure document completeness, accuracy, and compliance.
• Generate TMF quality metrics and status reports for sponsors and study teams.
• Partner with Project Managers and Clinical Research Associates (CRAs) to maintain inspection readiness throughout the study lifecycle.
• Support sponsor audits and regulatory inspections, including document retrieval and issue resolution.
• Lead TMF reconciliation activities with study teams and investigator sites.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree