On-site TMF Master File Specialist | Regulatory Expert

Pharmaron Beijing Co. Ltd.; 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 is seeking a Trial Master File Specialist to ensure TMFs are compliant, complete, and inspection-ready for clinical trials in Baltimore, MD on-site. You will own sponsor TMFs from study start-up through closeout, develop TMF plans, and act as the SME for eTMF systems, ensuring adherence to ICH-GCP and CDISC TMF standards.

The role requires strong attention to detail, excellent organizational and communication skills, and the ability to manage multiple studies in a fast-paced

Qualifications

• 5+ years TMF, clinical document management, or regulatory experience in CRO/biotech/pharma.
• Associate's degree with 5+ years TMF experience.
• Bachelor's degree with 3+ years TMF experience.
• Proficiency with Microsoft Office including Outlook, Word, Excel.

Responsibilities

• Own and manage sponsor 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.
• Ensure TMFs are maintained in accordance with ICH-GCP guidelines and regulatory requirements.
• Conduct ongoing TMF quality reviews to ensure 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

Clinical docs

ICH-GCP

eTMF

Regulatory knowledge

Education

Associate degree

Bachelor's degree

Tools

MS Office

Outlook

MS Word

Job description

Pharmaron is seeking a Trial Master File Specialist to ensure TMFs are compliant, complete, and inspection-ready for clinical trials in Baltimore, MD on-site. You will own sponsor TMFs from study start-up through closeout, develop TMF plans, and act as the SME for eTMF systems, ensuring adherence to ICH-GCP and CDISC TMF standards.

The role requires strong attention to detail, excellent organizational and communication skills, and the ability to manage multiple studies in a fast-paced