Electronic Trial Master File Specialist

Job Title: Electronic Trial Master File Specialist

Job Number: 35758

Location: , 

Job Description

The eTMF Specialist is responsible for the daily management of the electronic Trial Master File, including overseeing the review and approval of eTMF documents and generating reports to assess completeness, accuracy, and timeliness. This role emphasizes ensuring that document management activities comply with ICH-GCP guidelines, regulatory requirements, and standard operating procedures (SOPs). Additionally, the specialist will ensure that eTMFs for clinical studies remain inspection-ready at all times.

Responsibilities

• Develop study-specific eTMF plans for assigned clinical studies.
• Perform quality control on documents submitted to the eTMF, ensuring compliance with established criteria.
• Ensure clinical trial documentation meets eTMF specifications, ICH-GCP guidelines, regulatory requirements, and SOPs.
• Address questions related to document filing and the eTMF system.
• Remediate documents failing TMF quality control/review and provide best practice recommendations.
• Maintain up-to-date Essential Document Lists (EDLs).
• Monitor and communicate study-specific eTMF trends to relevant teams.
• Support inspection/audit activities, including preparation and corrective action plans.
• Stay current with the TMF Reference Model, industry best practices, and regulatory requirements.
• Perform tasks in compliance with regulations and company policies, including timely documentation and required training.
• Bring a proactive approach to work and take on additional responsibilities as needed.

Required Skills

• 3+ years of relevant clinical research and eTMF experience in biotechnology, pharmaceuticals, or CROs.
• Experience with eTMF system software and handling clinical trial-related documents.
• Strong understanding of the clinical trial process and knowledge of the Trial Master File Reference Model Structure.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical document management.
• Proficient in MS Office Suite, with familiarity in Smartsheets and SharePoint.
• Experience in biotech, pharmaceuticals, or medical devices preferred.
• Related vocational experience (e.g., co-ops, internships) a plus.
• Proven success in high-growth, dynamic environments.
• Demonstrated innovation, problem-solving, and leadership in fast-paced projects.
• Hands-on experience and expertise in relevant areas.
• Strong team-player and collaborator in small working environments.
• Highly organized and detail-oriented with a focus on quality results.
• Excellent verbal and written communication skills, with the ability to translate technical concepts into user-friendly documentation.
• Strong professionalism, confidence, and ethical standards.