Clinical eTMF Consultant

Job Title: Clinical eTMF Consultant

Department: Clinical Operations

Position Summary:

The Clinical eTMF Specialist is responsible for managing and maintaining the Electronic Trial Master File (eTMF) system to ensure compliance with regulatory requirements, internal quality standards, and study timelines. This role ensures that all clinical trial documentation is complete, accurate, and inspection-ready at all times. The eTMF Specialist serves as a key liaison between Clinical Operations, Quality Assurance, Regulatory Affairs, and external partners such as CROs and vendors.

Key Responsibilities:

• Oversee setup, configuration, and ongoing management of the eTMF system for assigned clinical studies.
• Ensure that all essential documents are filed accurately and in accordance with ICH-Google Cloud Platform, 21 CFR Part 11, and company SOPs.
• Perform quality control (QC) checks on uploaded documents to ensure completeness, accuracy, and proper metadata tagging.
• Monitor TMF completeness metrics and collaborate with study teams to close gaps or resolve discrepancies.
• Train study team members and CROs on eTMF best practices, workflows, and compliance expectations.
• Support inspection readiness activities and participate in audits (internal and external).
• Generate and distribute TMF metrics and reports to stakeholders on a routine basis.
• Partner with IT or vendor support teams to troubleshoot eTMF system issues and support upgrades or enhancements.
• Maintain TMF Index mapping and document naming conventions across studies.
• Contribute to continuous improvement of TMF processes and SOPs.

Qualifications:

Education:

• Bachelor's degree in Life Sciences, Healthcare, Information Management, or a related field.

Experience:

• 2 5 years of experience managing Trial Master Files (TMF/eTMF) within a pharmaceutical, biotech, or CRO environment.
• Familiarity with eTMF platforms (e.g., Veeva Vault, PhlexTMF, Wingspan, MasterControl, or similar).
• Solid understanding of ICH-Google Cloud Platform guidelines and regulatory documentation requirements.
• Experience supporting audits and inspections (FDA, EMA, MHRA, etc.).

Skills:

• Strong attention to detail and organizational skills.
• Proficient in document management systems and metadata handling.
• Excellent written and verbal communication skills.
• Ability to work effectively across cross-functional teams in a global environment.

Preferred Qualifications:

• eTMF certification or experience as an eTMF Administrator.
• Experience with clinical systems integration (CTMS, EDC, etc.).
• Knowledge of Quality Management Systems (QMS).
• Prior experience supporting clinical study start-up and close-out activities.

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