TMF Specialist: Audit-Ready Records & eTMF Expert

Experis Technology Group; Bethesda (MD); On-site; USD 37,000 - 62,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Account

401(k) with Match

Weekly Pay

Job summary

Experis Technology Group is seeking a TMF Specialist for our client in Bethesda, MD. The role focuses on TMF setup, quality management, reporting, and QA to ensure inspection readiness and compliance with ICH/GCP and SOPs.

You will manage TMF documentation, filings, and cross-functional coordination, supporting retrievals and audits as needed. Strong attention to detail and communication are essential for success.

Qualifications

• Strong attention to detail and follow-through to support inspection readiness.
• Effective written and verbal communication for internal/external customers.
• Proactive problem-solving and analytical skills for TMF issues.
• Ability to coordinate cross-functionally across teams.

Responsibilities

• Own TMF setup, quality management, reporting, and QA activities.
• Ensure TMF document quality and completion, filing, maintenance, and TMF tracking for clients.
• Maintain documentation with eTMF specs, ICH/GCP guidelines, and SOPs.
• Verify new/updated records are accurately entered and maintained per SOPs.
• Support timely fulfillment of client requests for TMF retrieval and audit readiness.

Skills

Attention to detail

Communication skills

Cross-functional coordination

Problem solving

Customer focus

Tools

Veeva Vault

Trial Interactive

Job description

Experis Technology Group is seeking a TMF Specialist for our client in Bethesda, MD. The role focuses on TMF setup, quality management, reporting, and QA to ensure inspection readiness and compliance with ICH/GCP and SOPs.

You will manage TMF documentation, filings, and cross-functional coordination, supporting retrievals and audits as needed. Strong attention to detail and communication are essential for success.