Remote eTMF Quality Lead for Clinical Trials

Artivion, Inc.; Kennesaw (GA); Remote; USD 70,000 - 100,000; Full time

Job summary

Artivion, Inc. in the Atlanta metropolitan area is seeking a Clinical eTMF Specialist to manage the electronic Trial Master File across clinical trials, ensuring GCP, ICH guidelines and SOP compliance. You will collaborate with study teams, CROs, and QA to keep inspection readiness and accurate, timely documentation. Travel may be required.

You will monitor quality metrics, perform QC checks, support inspections, and contribute to SOP development and system enhancements.

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.

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 elevate 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.

Skills

Attention to detail

Communication skills

Time management

Team player

Education

Bachelor’s degree in Life Sciences

Tools

Florence

Veeva Vault

Job description

Artivion, Inc. in the Atlanta metropolitan area is seeking a Clinical eTMF Specialist to manage the electronic Trial Master File across clinical trials, ensuring GCP, ICH guidelines and SOP compliance. You will collaborate with study teams, CROs, and QA to keep inspection readiness and accurate, timely documentation. Travel may be required.

You will monitor quality metrics, perform QC checks, support inspections, and contribute to SOP development and system enhancements.