TMF Specialist

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

Our client, a Clinical Research Organization, is seeking a TMF Specialist to join their team. As a TMF Specialist, you will be part of the Records Management / Clinical Operations support team, helping ensure trial documentation is organized, accurate, and inspection-ready. The ideal candidate will have strong attention to detail, a customer-focused mindset, and the ability to manage multiple competing priorities with confidence—skills that will align successfully in the organization.

Job Title:TMF Specialist

Location:Bethesda, Maryland

Pay Range: $40-45/hr depending on years of experience

What's the Job?

• Own TMF set-up, quality management, reporting, and TMF quality control/quality assurance activities.
• Ensure overall TMF document quality and completion, including accurate document filing and maintenance, cross-functional document coordination, and TMF tracking and reporting to internal and external clients.
• Maintain clinical trial documentation consistency with eTMF specifications, ICH/GCP guidelines, regulatory requirements, and applicable SOPs.
• Verify that new and updated record information is entered accurately and maintained in accordance with TMF storage SOPs, processes, and data structure for inspection readiness.
• Support timely fulfillment of client requests for TMF retrieval, reproduction, re-filing, and requested records or electronic images (e.g., PDF, JPEG), while assisting with inspection and audit-ready activities.

What's Needed?

• Previous experience working in eTMF system software; Veeva Vault and/or Trial Interactive preferred.
• Strong understanding of clinical research concepts and processes, with solid knowledge of ICH-GCP guidelines and regulatory requirements for clinical document management.
• Excellent organizational skills with outstanding attention to detail and follow-through to support inspection readiness.
• Effective written and verbal communication skills for internal and external customers, including the ability to coordinate cross-functionally.
• Proactive problem-solving and analytical skills to identify solutions to technical problems of varying complexity; ability to advise project team members on key TMF issues.

What's in it for me?

• Play a direct role in ensuring TMF is audit ready and that documentation meets ICH/GCP and regulatory expectations.
• Work with eTMF records management processes and serve as a liaison between eTMF systems and internal/external stakeholders.
• Build confidence by supporting inspection and audit readiness, including QC review and approval of documents for accurate entry.
• Strengthen your expertise as a subject matter expert (SME) for TMF-related questions and guidance for project staff.
• Contribute to continuous improvement by supporting digital records/TMF training materials, SOPs, and guidelines.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay