Sr. eTMF Manager

Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. 

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking Sr. eTMF Manager as part of the Clinical Operations team based Remote. 

Role Overview

Highly experienced Senior eTMF Manager will 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. This position involves close collaboration with cross-functional teams, training users, and implementing best practices to optimize the use of the eTMF system. As a biotech company transitioning 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 working closely with the Sr. Director of Clinical Operations, Clinical QA and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality to ensure eTMF is always inspection ready. In addition, the position will ensure program consistency across studies, drive research and eTMF operational excellence through process improvement, SOP creation and development and represent and lead eTMF function at internal and external meetings.

Key Responsibilities  

Working closely with the Sr. Director of Clinical Research Operations, Clinical QA, and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality etc. to manage eTMF.

•  System Management and Oversight:
  • Oversee the configuration, maintenance, and day-to-day operations of the Veeva eTMF system, ensuring all study documentation is accurate, complete, and GCP-compliant. 
  • Monitor eTMF completeness, timeliness, and quality, identifying gaps and implementing corrective actions as needed.
  • Ensure the eTMF is always inspection-ready, conducting regular quality checks and audits.
  • The eTMF Manager will oversee the eTMF lifecycle, ensure compliance with regulatory requirements, and act as the primary point of contact for system-related inquiries.
• eTMF Strategy and Implementation:
  • Develop and execute a comprehensive eTMF strategy, aligning with the company’s clinical and regulatory goals.
  • Lead the ongoing management and optimization of the Veeva eTMF system, ensuring it meets GCP, FDA, EMA, and other relevant regulatory standards.
  • Establish and document best practices, SOPs, and workflows for eTMF management to ensure consistent and compliant document handling.
  • Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
• Training and Support:
  • Provide expert guidance and training to internal teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, as well as external partners (CROs, vendors) on the use of the Veeva eTMF system.
  • Serve as the primary point of contact for eTMF-related issues, providing solutions and support to ensure seamless operations.
• Collaboration and Stakeholder Management:
  • Work closely with cross-functional teams t