Posted today
Top Secret
$40,000 - $50,000
Unspecified
Bethesda, MD (On-Site/Office)
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:
Qualifications of the TMF Specialist:
Compensation for the TMF Specialist:
This job opens for applications on 1/21/2026. Applications for this job will be accepted for at least 30 days from the posting date.
#LI-LS3 #LI-HYBRID
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Essential Duties of the TMF Specialist:
- Responsible for TMF set-up, quality management, reports and metrics, and TMF QC/QA.
- Accountable for overall TMF document quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, and TMF tracking.
- 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:
- $40,000 - $50,000 (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 1/21/2026. Applications for this job will be accepted for at least 30 days from the posting date.
#LI-LS3 #LI-HYBRID
Keywords: 401k, 401k match, pto, paid time off, holiday, medical, dental, health, culture, ts/sci, top secret, government clearance, security clearance, ssbi, secret clearance, dod clearance, department of defense, army, navy, military, marines, air force, clinical research organization, cro, trial master file, tmf specialist, trial master file specialist, sop, etmf, ich, gcp, good clinical practice, quality control, quality assurance, quality management, document coordination, tmf tracking, tmf storage, tmf reference model, reference model, tmf retrieval, tmf storage, etmf records, veeva vault, veeva, veeva trial, clinical research, regulatory guidelines, science, biology, chemistry, biochemistry, fda, ema,
group id: 10430981
