Company Overview:
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,600 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.
Overview:
The Clinical eTMF Specialist is responsible for the management, oversight, and quality control of the electronic Trial Master File (eTMF) throughout the lifecycle of clinical trials. This role ensures compliance with Good Clinical Practice (GCP), ICH guidelines, company Standard Operating Procedures (SOPs), and regulatory requirements. The specialist will collaborate with internal teams, CROs, and study sites to maintain inspection readiness and ensure accurate, complete, and timely documentation within the eTMF system.
Responsibilities:
- Collaborate with clinical study team to manage study electronic Trial Master File (eTMF) to ensure completeness, accuracy, and compliance with regulatory requirements.
- Monitor eTMF quality metrics and proactively address gaps or issues.
- Perform regular quality control checks and reconciliation of documents against the eTMF reference model.
- Partner with cross-functions to ensure TMF quality, timely filing and proper indexing of essential documents.
- Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CROs to ensure compliance and alignment on eTMF standards.
- Provide training and support to study teams, sites, and vendors on eTMF processes and best practices.
- Ensure the eTMF remains audit- and inspection-ready at all times.
- Support preparation for regulatory inspections and sponsor audits.
- Identify and escalate compliance risks and document-related issues in a timely manner.
- Contribute to the development and refinement of SOPs, work instructions, and training materials related to eTMF.
- Assist with system enhancements, upgrades, and user acceptance testing (UAT).
- Will effectively complete "other" functions that may be assigned.
Qualifications:
- 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. Posses a solution-oriented mindset and able to develop innovative solutions to issues.