Remote Clinical eTMF Specialist, Compliance & Audits

CryoLife, Inc.; Kennesaw, Northern (GA, KY); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Artivion, Inc. is seeking a Clinical eTMF Specialist to manage the electronic Trial Master File across clinical trials, ensuring GCP/ICH compliance and inspection readiness. You will collaborate with cross-functional teams, CROs, and study sites to maintain accurate, complete documentation in eTMF systems.

Responsibilities include QC, indexing, training, and supporting regulatory inspections, with travel as required. Prior TMF/eTMF experience and knowledge of ICH-GCP FDA EMA is required.

Qualifications

• Bachelor’s degree in Life Sciences, Clinical Research, or related field.
• 2–4 years of clinical trial documentation or eTMF experience.
• Knowledge of ICH-GCP and global regulatory requirements.
• Hands-on experience with Florence, Veeva Vault, or similar eTMF systems.

Responsibilities

• Manage electronic TMF to ensure completeness and regulatory compliance.
• Perform quality control checks and reconcile documents against the TMF model.
• Coordinate with Clinical Operations, QA, Regulatory Affairs, and CROs on eTMF standards.
• Provide training and support on eTMF processes to study teams and vendors.
• Ensure eTMF remains audit- and inspection-ready at all times.

Skills

Attention to detail

Communication skills

Team collaboration

Time management

Travel willingness

Education

Bachelor’s degree in Life Sciences/Clinical Research

Tools

Veeva Vault

Florence TMF

eTMF systems

Job description

Artivion, Inc. is seeking a Clinical eTMF Specialist to manage the electronic Trial Master File across clinical trials, ensuring GCP/ICH compliance and inspection readiness. You will collaborate with cross-functional teams, CROs, and study sites to maintain accurate, complete documentation in eTMF systems.

Responsibilities include QC, indexing, training, and supporting regulatory inspections, with travel as required. Prior TMF/eTMF experience and knowledge of ICH-GCP FDA EMA is required.