Description
The TMF Coordinator will maintain the quality, completeness, and regulatory compliance of Trial Master File documentation for clinical trials, including paper and electronic records. The role covers TMF oversight, ICH-GCP, FDA, and EMA compliance, ALCOA+ data integrity, inspection readiness, document filing and indexing, eTMF systems, quality control, issue resolution, stakeholder collaboration, and continuous improvement. It requires 1–3 years of clinical trial TMF management experience, working knowledge of eTMF platforms and regulatory requirements, and remote work; a bachelor’s degree in life sciences or a related field is preferred.
