Moderna Theraputics-posted 8 months ago
Full-time • Mid Level
Remote • Cambridge, MA
Professional, Scientific, and Technical Services

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Moderna Services, Inc. seeks an eTMF Manager for its Cambridge, Massachusetts location. The eTMF Manager will lead the execution of TMF Operations processes and strategy, ensuring compliance with U.S. and international regulatory requirements. This role involves maintaining effective communication with clinical study teams, CRO staff, and eTMF vendor personnel throughout the lifecycle of clinical trials. The eTMF Manager will also support TMF document filing, perform quality checks, and author various TMF-related documents. Additionally, the role includes delivering KPI reports, managing TMF completeness, and supporting system updates and process improvements.

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