TMF Specialist

Piper Companies; Bethesda (MD); Híbrido; USD 50.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits

401k with ADP

Paid holidays & PTO

Descripción de la vacante

Piper Companies in Bethesda, MD is seeking a TMF Specialist to manage TMF set-up, quality management, reporting, and QA for a clinical research program. Hybrid role with three remote days per week, based in Bethesda.

You will ensure documentation complies with ICH/GCP, FDA, EMA TMF requirements, and SOPs, and maintain records for inspection readiness. Candidates should have 1+ year TMF experience and a BA/BS in a science or healthcare field.

Formación

• 1+ year TMF experience.
• Knowledge of FDA, ICH, EMA TMF requirements.
• TMF monitoring experience; TMF Plans/Indexes.
• Minimum B.A. or B.S. in science or healthcare field.

Responsabilidades

• TMF set-up, quality management, reports and metrics, and TMF quality control/quality assurance.
• Ensure overall TMF document quality and completion, including filing and maintenance, cross-functional coordination, and TMF tracking and reporting to clients.
• Ensure documentation is consistent with eTMF specs, ICH/GCP, regulatory requirements, and SOPs.
• Maintain record information per TMF storage SOPs for inspection readiness.

Conocimientos

TMF experience

FDA/ICH/EMA TMF requirements

TMF monitoring

Veeva Vault

Trial Interactive

Educación

Bachelor's degree in science or healthcare field

Herramientas

Veeva Vault

Trial Interactive

Descripción del empleo

Piper Companies is looking for a TMF Specialist to join a clinical research organization (CRO). This is a hybrid position with 3 remote days out of Bethesda, MD.

Essential Duties of the TMF Specialist:

• Responsible for TMF set-up, quality management, reports and metrics, and TMF quality control/quality assurance.
• Accountable for overall TMF document quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, and TMF tracking and reporting to internal and external clients.
• Ensures clinical trial documentation is consistent with eTMF specifications, ICH/GCP guidelines, regulatory requirements, and applicable SOPs.
• Ensures that all new and updated record information is accurately entered and is maintained in accordance with TMF storage SOP's, processes and data structure for inspection readiness.

Qualifications of the TMF Specialist:

• 1+ year of TMF (trial master file) experience
• Experience with TMF review and with knowledge of FDA, ICH, and EMA TMF requirements
• TMF monitoring experience, generation of TMF Plans and Indexes.
• Experience with Veeva Vault and Trial Interactive
• Minimum B.A. or B.S. in science or healthcare field

Compensation for the TMF Specialist:

• $50,000 - $85,000 (based on experience)
• 3 remote days per week
• Comprehensive benefit package; Cigna Medical, Cigna Dental, Vision, 401k w/ ADP, PTO, paid holidays, Sick Leave as required by law, paid holidays.

This job opens for applications on 10/2/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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