Jobs via Dice ยท 1 day ago
Clinical eTMF Consultant
Massachusetts, United States
Full-time
Onsite
Mid, Senior Level
2+ years expJobs via Dice is seeking a Clinical eTMF Consultant responsible for managing and maintaining the Electronic Trial Master File (eTMF) system. This role ensures compliance with regulatory requirements and internal quality standards while overseeing clinical trial documentation to be inspection-ready at all times.
Computer Software
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
Qualification
Required
Bachelor's degree in Life Sciences, Healthcare, Information Management, or a related field
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.)
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
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
Company
Jobs via Dice
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0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase