TMF Specialist Levels -III ; Levels -III

Piper Health & Sciences is seeking a TMF Specialist to join a leading full-service Contract Research Organization (CRO) located in the greater Washington, DC/Montgomery County area. The TMF Specialist will support Trial Master File (TMF) activities across clinical trials, ensuring regulatory compliance, inspection readiness, and adherence to global TMF standards
.

This role is ideal for TMF professionals who thrive in fast-paced CRO environments and enjoy maintaining inspection‑ready TMFs across multiple clinical studies.

Please note this is a full-time, hybrid position
, with 2 onsite days and 3 remote days per week
. The role is open to Level I, II, and III candidates
, depending on experience, with increasing responsibility and leadership expectations at higher levels. There are five (5) TMF openings available, and referrals are welcome.

Responsibilities of the TMF Specialist Includes:

• Support day-to-day Trial Master File (TMF) operations across assigned clinical studies
• Perform TMF review, reconciliation, and quality control activities to ensure completeness, accuracy, and inspection readiness
• Ensure TMF compliance with FDA, ICH, and EMA regulatory requirements
• Utilize electronic TMF systems, including Veeva Vault
  , Trial Interactive
  , or similar platforms
• Conduct TMF monitoring
  , including ongoing oversight of document completeness and timeliness
• Develop, maintain, and execute TMF Plans and TMF Indexes in accordance with study requirements
• Identify TMF gaps, risks, and trends; collaborate with study teams to drive timely resolution
• Support audit and inspection readiness activities
  , including documentation review and response to TMF findings
• Generate and maintain TMF metrics and documentation to support compliance and quality initiatives

• Provide oversight and mentoring to junior TMF staff participating in TMF reviews
• Support training initiatives and provide procedural guidance on TMF processes

• Manage and oversee TMF staff
  , including workload planning and performance guidance
• Lead the development and maintenance of foundational TMF documents
  , including:
  • TMF Plans
  • TMF Indexes
  • SOPs and other governing documents
• Serve as a TMF subject matter expert
  , supporting inspection readiness and continuous improvement initiatives

Qualifications of the TMF Specialist Includes:

• Bachelor’s degree (B.A. or B.S.) in a science, healthcare, or related field (required)
• TMF experience aligned with one of the following levels:
  • Level I: 0–2 years of relevant TMF or clinical operations experience
  • Level II: 2–4 years of TMF experience, including mentoring or oversight of junior staff
  • Level III: 4+ years of TMF experience, including team management and document governance responsibilities
• Strong working knowledge of Trial Master File requirements and applicable global regulations (FDA, ICH, EMA)
• Hands-on experience with eTMF systems
  , with emphasis on Veeva Vault and Trial Interactive
• Demonstrated experience conducting TMF reviews and supporting inspection readiness
• High attention to detail with strong organizational and time‑management skills
• Excellent written and verbal communication skills
• Ability to work effectively in a hybrid environment and collaborate with cross‑functional clinical teams

• Pay Range: $41,600.00 - $56,160.00 per year (equivalent to $20.00 - $27.00 per hour), based on experience and certifications.
• Comprehensive Benefits: CIGNA Medical, Dental, Vision; 401k through ADP, sick leave as required by law.

1/22/2026. Applications for this job will be accepted for at least 30 days from the posting date.

#LI-AW1

#LI-HYBRID