TMF Compliance Specialist — eTMF Expert

Pharmaron; Baltimore (MD); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Pharmaron in Baltimore, MD seeks a Trial Master File Specialist to keep TMFs compliant, complete, and inspection-ready throughout the study lifecycle. You will own TMF management, develop filing strategies, and support audits with CRAs and sponsors.

The role requires 5+ years in TMF/clinical document management in CRO/biopharma, a Bachelor’s or Associate degree, and strong knowledge of ICH-GCP and eTMF systems. On-site work with competitive benefits and career growth opportunities.

Qualifications

• 5+ years in TMF, clinical document management, clinical operations, or regulatory within CRO/biotech/pharma.
• Experience with electronic TMF (eTMF) systems and processes.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Familiarity with CDISC TMF Reference Model.
• Excellent organizational and communication skills.

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 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.

Skills

TMF management

Regulatory knowledge

Documentation control

Communication

Education

Associate's degree

Bachelor's degree

Tools

Microsoft Office

eTMF systems

ICH-GCP familiarity

CDISC TMF Model

Job description

Pharmaron in Baltimore, MD seeks a Trial Master File Specialist to keep TMFs compliant, complete, and inspection-ready throughout the study lifecycle. You will own TMF management, develop filing strategies, and support audits with CRAs and sponsors.

The role requires 5+ years in TMF/clinical document management in CRO/biopharma, a Bachelor’s or Associate degree, and strong knowledge of ICH-GCP and eTMF systems. On-site work with competitive benefits and career growth opportunities.