TMF Specialist

Zachary Piper Solutions is seeking a TMF Specialist to support our client in Bethesda, MD. The TMF Specialist will manage the setup, maintenance, quality, and inspection readiness of Trial Master Files (TMF) across one or more clinical studies, ensuring compliance with ICH/GCP, FDA, and EMA requirements while serving as a subject matter expert to project teams.

Responsibilities of TMF Specialist include:

• Manage TMF setup, maintenance, quality control, and quality assurance activities across clinical trials
• Ensure TMF completeness, accuracy, and timeliness in alignment with eTMF specifications, ICH/GCP, and regulatory requirements
• Perform QC review and approval of TMF documents to maintain inspection readiness
• Coordinate cross-functional document collection, filing, tracking, and reporting within the eTMF
• Serve as TMF subject matter expert, advising project teams on TMF standards, issues, and best practices
• Support audit and inspection readiness activities, including record retrieval and study closeout
• Assist with TMF SOPs, training materials, and mentoring of junior staff as applicable Qualifications for the TMF Specialist include:
• Bachelor's degree in science, healthcare, or a related field
• Experience working with eTMF systems (Veeva Vault or Trial Interactive preferred)
• Strong knowledge of ICH-GCP guidelines and regulatory requirements for clinical documentation
• Experience reviewing TMFs for completeness, timeliness, and accuracy
• Excellent organizational skills with strong attention to detail
• Effective written and verbal communication skills with internal and external stakeholders
• Proficiency with Microsoft Office applications Compensation for the TMF Specialist includes:

Salary Range:

$20/hour - $27/hour depending on years of experience

Full Benefits Package:

PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset Keywords TMF Specialist, Trial Master File, eTMF, Clinical Operations, Clinical Trials, Clinical Research, ICH-GCP, GCP Compliance, FDA Regulations, EMA Regulations, TMF Reference Model, Inspection Readiness, Audit Readiness, TMF Quality Control, TMF Quality Assurance, Document Management, Clinical Documentation, Records Management, Veeva Vault, Trial Interactive, eTMF Systems, SOP Development, SOP Compliance, TMF Setup, TMF Maintenance, TMF Metrics, TMF Reporting, TMF Tracking, Cross-Functional Collaboration, Regulatory Compliance, Quality Management, QC Review, Document Filing, Study Closeout, TMF Archiving, Inspection Support, Audit Support, TMF Training, Staff Mentoring, Clinical Governance, Data Integrity, Risk-Based Quality Management, Clinical Study Support, Sponsor Oversight, CRO Collaboration, Records Retrieval, Electronic Records, PDF Imaging, Clinical Compliance, Regulatory Documentation, Trial Management, Project Support, MS Office, Process Improvement, Metrics and KPIs, Client Communication, Timeline Management, eClinical Systems, TMF Plans, TMF Indexes #LI-KG1 #LI-HYBRID