TMF Specialist

Piper Companies is seeking a TMF Specialist to support a leading Clinical Research Organization (CRO) through hybrid work in Bethesda, MD. This role is ideal for someone experienced with eTMF systems who thrives in a quality driven, fast paced clinical operations environment.

Responsibilities of the TMF Specialist:

• Manage the setup, organization, and overall quality of the Trial Master File (TMF), ensuring accurate filing and compliance with ICH/GCP and internal eTMF standards.

• Monitor TMF completeness, maintain inspection‑ready documentation, and provide status reporting and issue escalation to project teams and stakeholders.

• Handle TMF document retrieval, updates, and re‑filing requests to support audits, inspections, and ongoing study needs.

• Contribute to process improvements by supporting updates to SOPs, templates, and training materials while guiding teams on TMF expectations and best practices.

• Serve as a TMF resource to project staff; higher‑level specialists may mentor or oversee junior reviewers.

Qualifications of the TMF Specialist:

• Accepting experience levels I (0 - 2 years), II (2 - 4 years), and III (4 + years).

• Experience working within eTMF platforms, with strong preference for Veeva Vault and Trial Interactive.

• Knowledge of clinical research processes and documentation requirements.

• Strong understanding of ICH‑GCP guidelines and regulations related to TMF management.

• Strong communication skills and ability to partner with cross‑functional clinical teams.

• Proven ability to troubleshoot issues, recommend solutions, and work with technical systems.

• Experience training or mentoring staff is strongly preferred for mid‑ or senior‑level candidates.

• Fully proficient with Microsoft Office applications.

• COVID‑19 vaccination required (boosters not required at this time).

• Bachelor’s degree in a science or healthcare‑related discipline required.

• Must be eligible to work in the United States.

Compensation of the TMF Specialist:

• Salary Range: $25.00 – $32.00/hourly depending on years of experience

• Comprehensive benefit package; Cigna Medical, Cigna Dental, Vision, 401k w/ ADP, PTO, paid holidays, Sick Leave as required by law

This job opens for applications on February 6, 2026. Applications for this job will be accepted for at least 30 days from the posting date.

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