Clinical eTMF Specialist
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Job Description
Clinical eTMF Specialist managing compliant trial documentation for Artivion, a cardiac and vascular medical device company. Maintaining inspection-ready eTMF systems across clinical studies.
Responsibilities:
- Manage and oversee the electronic Trial Master File (eTMF) throughout the clinical trial lifecycle
- Ensure eTMF completeness, accuracy, compliance, and inspection readiness
- Monitor eTMF quality metrics and address gaps or issues
- Perform quality control checks and reconcile documents against the eTMF reference model
- Coordinate with Clinical Operations, Quality Assurance, Regulatory Affairs, CROs, study sites, vendors, and cross-functional teams
- Provide training and support on eTMF processes and best practices
- Support regulatory inspections and sponsor audits
- Identify and escalate compliance risks and document-related issues
- Contribute to SOPs, work instructions, and training materials
- Assist with system enhancements, upgrades, and user acceptance testing (UAT)
- Complete other assigned functions
Requirements:
- Bachelor’s degree in Life Sciences, Clinical Research, or a related field (or equivalent experience)
- Minimum of 2–4 years of experience in clinical trial documentation, TMF, or eTMF management
- Solid understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements
- Hands-on experience with eTMF systems (e.g., Florence, Veeva Vault, or similar)
- Experience working TMF CDISC reference model and cross-functional clinical processes preferred
- Strong attention to detail, organizational, and time management skills
- Excellent written and oral communication and presentation skills
- Excellent interpersonal skills and ability to work in a team-based, collaborative environment
- Ability to independently plan, organize, coordinate, manage and execute assigned tasks and multiple projects
- Willingness to travel
- Good understanding of applicable regulations
- Highly self-motivated, well organized, and confident
- Possess a solution-oriented mindset and able to develop innovative solutions to issues
Benefits:
- Reasonable accommodation for applicants with disabilities
- Willingness to travel is part of the role
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