TMF Specialist

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

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.