TMF Specialist - 172430

Piper Companies; Bethesda (MD); On-site; USD 28,000 - 48,000; Full time

Job summary

Piper Companies is seeking a TMF Specialist in Bethesda, MD to manage TMF setup, quality oversight, and documentation across clinical trials. The role focuses on maintaining inspection readiness, ensuring compliance with ICH-GCP and regulatory standards, and supporting client communications and training initiatives.

The position requires experience with eTMF systems (Veeva Vault or Trial Interactive) and strong organizational skills, with a Bachelor’s degree in a science or healthcare field.

Qualifications

• Experience with eTMF systems (Veeva Vault or Trial Interactive preferred).
• In-depth knowledge of ICH-GCP guidelines and TMF regulatory requirements.
• Bachelor’s degree in science or healthcare and strong document management skills.

Responsibilities

• Manage TMF setup, quality oversight, reporting, metrics, and QC activities.
• Maintain TMF document quality and completeness; proper filing, tracking, and reporting.
• Ensure compliance with eTMF specs, ICH/GCP, regulatory requirements, and SOPs.
• Maintain TMF records to support inspection readiness.
• Respond to client requests for TMF retrieval, reproduction, and delivery of electronic records.
• Assist in developing TMF training materials and SOPs; train staff as needed.
• Support audit and inspection readiness activities and TMF inspection readiness.
• Stay updated on TMF Reference Model standards and regulatory requirements.
• Act as liaison between eTMF records management and clients; monitor project deadlines.

Skills

Attention to detail

Organizational skills

Written and verbal communication

Multi-priority management

Problem-solving

TMF subject matter guidance

Staff training/mentoring

Education

Bachelor’s degree in science or healthcare

Tools

Veeva Vault

Trial Interactive

Microsoft Office

Job description

Piper Companies is looking for a TMF Specialist to join a clinical research organization located in Bethesda, MD.

Responsibilities of the TMF Specialist include:

• Managing TMF set-up, quality oversight, reporting, metrics, and quality control activities
• Maintaining overall TMF document quality and completeness, including proper filing, coordination, tracking, and reporting
• Ensuring clinical trial documentation complies with eTMF specifications, ICH/GCP guidelines, regulatory requirements, and internal SOPs
• Accurately maintaining all TMF records in accordance with SOPs and data standards to support inspection readiness
• Responding to client requests for TMF retrieval, reproduction, re-filing, and delivery of electronic records
• Supporting the development and maintenance of TMF training materials, SOPs, and guidelines, including training staff as needed
• Assisting with audit and inspection readiness activities and ensuring the TMF remains inspection ready
• Staying current on TMF Reference Model standards, regulatory requirements, and industry best practices
• Serving as a liaison between eTMF records management and internal and external clients
• Monitoring project activities to ensure deadlines and deliverables are metActing as a subject matter expert on TMF-related matters and providing guidance to project staff and subcontractors
• Performing quality control reviews of TMF documents to ensure accuracy
• Coordinating retrieval of requested records and preparing closed studies for transfer within agreed timelines
• Assisting management with records management planning, cost proposals, and resource forecasting
• Performing task management and, depending on experience level, line management responsibilities

Qualifications for the TMF Specialist include:

• Experience working with eTMF systems; Veeva Vault or Trial Interactive preferred
• Strong understanding of clinical research processes and document management requirements
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements related to TMF management
• Excellent organizational skills with strong attention to detail
• Effective written and verbal communication skills
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment
• Strong problem-solving and analytical skills
• Experience advising project teams on TMF-related issues
• Experience training, mentoring, and coaching staff
• Ability to build and maintain positive working relationships across teams and management
• Proficiency in Microsoft Office
• Bachelor’s degree in a science or healthcare-related field required

Compensation for TMF Specialist includes:

• Rate Range: $20-35/hr
• Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on August 19th, 2026. Applications will be accepted for at least 30 days from the posting date.

Keywords: eTMF Management, Trial Master File, TMF Reference Model, Veeva Vault, Trial Interactive, ICH‑GCP Compliance, FDA Regulations, EMA Requirements, Regulatory Inspection Readiness, TMF Quality Control, TMF Quality Assurance, Clinical Document Management, TMF Indexing, TMF Plans, Audit Readiness, Inspection Support, Metadata Management, Records Management, SOP Compliance, Clinical Operations, TMF Monitoring, Document Lifecycle Management, TMF Reconciliation, Quality Metrics Reporting, Electronic Records Management, TMF Archiving, Cross‑Functional Coordination, Risk‑Based TMF Management, Data Integrity, Vendor Oversight

#LI-MU1

#LI-ONSITE