Sr. eTMF Manager
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About The Position
Legend Biotech is seeking a highly experienced Senior eTMF Manager to lead the strategic management and oversight of our newly implemented Veeva eTMF system. This role is critical in ensuring that our clinical trial documentation is compliant with Good Clinical Practice (GCP) guidelines and regulatory requirements. The Senior eTMF Manager will work closely with cross-functional teams, training users, and implementing best practices to optimize the use of the eTMF system. As a biotech company transitioning from a manual document management system, the Senior eTMF Manager will play a key role in establishing, maintaining, and optimizing our eTMF processes. The ideal candidate will bring a blend of hands-on eTMF expertise and strategic vision to ensure that our studies are always inspection-ready. The position involves collaboration with the Sr. Director of Clinical Operations, Clinical QA, and various cross-functional teams, including safety, study monitoring, data management, biostatistics, and regulatory affairs. The Senior eTMF Manager will ensure program consistency across studies, drive research and eTMF operational excellence through process improvement, and represent and lead the eTMF function at internal and external meetings. This role requires a proactive approach to managing the eTMF lifecycle, ensuring compliance with regulatory requirements, and acting as the primary point of contact for system-related inquiries. In addition to overseeing the configuration and maintenance of the Veeva eTMF system, the Senior eTMF Manager will develop and execute a comprehensive eTMF strategy, aligning with the company's clinical and regulatory goals. The role also includes providing expert guidance and training to internal teams and external partners, ensuring seamless integration of eTMF processes into overall clinical trial operations. Continuous assessment and enhancement of eTMF processes and document workflows will be essential to improve efficiency, quality, and compliance, while staying current with industry best practices and regulatory updates.
