TMF Coordinator

Job Summary

Detail-oriented and highly organized, the full-time TMF Coordinator will manage the quality, completeness, and compliance of Trial Master File documentation remotely, ensuring alignment with global regulatory requirements and supporting clinical trial execution through effective document management.

Key responsibilities

• Maintain compliance with ICH-GCP, FDA, and EMA regulations while ensuring TMF content is inspection-ready
• Accurately file, classify, and index documents within the TMF, utilizing eTMF systems and Microsoft Office tools
• Perform quality control checks on TMF documents, identifying and resolving discrepancies to ensure overall accuracy and completeness

Required qualifications

• Bachelor's degree in Life Sciences or a related field (preferred)
• 1-3 years of experience in clinical trials TMF management
• Working knowledge of eTMF platforms and regulatory requirements
• Strong understanding of clinical trial record management and quality standards
• Ability to work remotely and manage multiple priorities in a fast-paced environment