TMF Specialist: Audit-Ready Records & eTMF Expert

ManpowerGroup; Bethesda (MD); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

401(k) Plus Match

Weekly Pay

Job summary

ManpowerGroup is seeking a TMF Specialist in Bethesda, MD to join the Records Management / Clinical Operations support team. You will own TMF setup, quality management, reporting, and QA activities to ensure inspection-ready documentation in line with ICH/GCP and SOPs.

You will maintain TMF quality, filing accuracy, cross-functional coordination, and timely response to client requests for TMF retrieval and imaging. Strong organization, communication, and problem‑solving skills are essential.

Qualifications

• Experience with eTMF systems (Veeva Vault/Trial Interactive preferred).
• Solid knowledge of ICH-GCP and regulatory requirements for TMF/documents.
• Excellent organizational skills and attention to detail for inspection readiness.
• Strong written and verbal communication for internal/external stakeholders.
• Proactive problem-solving and analytical skills for TMF issues.

Responsibilities

• Own TMF setup, quality management, reporting, and TMF QA activities.
• Ensure TMF document quality, filing, maintenance, and cross-functional coordination.
• Maintain TMF alignment with eTMF specs, ICH/GCP, regulatory requirements, and SOPs.
• Verify accurate record information entry and TMF data structure for inspection readiness.
• Support TMF retrieval, reproduction, re-filing, and audit-ready activities.

Skills

ETMF system experience

ICH-GCP knowledge

Organizational skills

Communication skills

Problem solving

Tools

Veeva Vault

Trial Interactive

Job description

ManpowerGroup is seeking a TMF Specialist in Bethesda, MD to join the Records Management / Clinical Operations support team. You will own TMF setup, quality management, reporting, and QA activities to ensure inspection-ready documentation in line with ICH/GCP and SOPs.

You will maintain TMF quality, filing accuracy, cross-functional coordination, and timely response to client requests for TMF retrieval and imaging. Strong organization, communication, and problem‑solving skills are essential.