TMF Coordinator

📋 Description

• Maintain in-depth knowledge of TMF structures (paper and electronic)
• Ensure compliance with ICH-GCP, FDA, and EMA regulations
• Apply ALCOA+ data integrity principles
• Support inspection readiness and audit activities
• Ensure proper management of essential clinical trial documentation
• Accurately file, classify, and index documents within the TMF

🎯 Requirements

• Bachelor’s degree in Life Sciences or a related field (preferred)
• 1-3 years experience in clinical trials TMF management
• Working knowledge of eTMF platforms and regulatory requirements
• Strong understanding of clinical trial record management and quality standards
• Working remotely