TMF Specialist - eTMF & Regulatory Compliance Expert

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 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.