We are looking for a TMF Coordinator to join our TMF Operations team. This role focuses on maintaining TMF documentation quality and compliance, essential for successful clinical trials.
As a pivotal member of the team, you will ensure that Trial Master File documentation adheres to global regulatory standards. Your attention to detail will guarantee that TMF content remains inspection-ready. You will engage closely with multidisciplinary teams to resolve discrepancies and support audit readiness efforts, thus playing a key role in the clinical trial process.
Key Responsibilities:
• Ensure adherence to ICH-GCP, FDA, and EMA regulations
• Manage filing and indexing of TMF documents
• Conduct thorough QC checks on TMF metadata
• Investigate gaps and discrepancies in documentation
• Proactively support cross-team collaboration
Requirements:
• In-depth understanding of TMF structures
• Proficiency in eTMF systems like Veeva Vault
• Robust problem-solving and analytical abilities
• Excellent time management and organizational skills
• Effective communication with stakeholders
Join us in optimizing the TMF processes and enhancing clinical trial documentation.
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📌 TMF Coordinator for Clinical Trials (London)
🏢 Alimentiv
📍 London