Sr. eTMF Manager

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 to integrate eTMF processes into overall clinical trial
    operations.
  • Collaborate with CROs, sites, and other stakeholders to ensure timely and compliant submission of trial documentation into the eTMF.
  • Collaborate closely with Clinical Operations, Quality Assurance, Regulatory Affairs, and other departments to ensure seamless eTMF integration across the organization. 
  • Work with study teams to ensure that all required documents are submitted to the eTMF in a timely and compliant manner.
• Process Improvement:
  • Continuously assess and enhance eTMF processes and document workflows to improve efficiency, quality, and compliance.
  • Stay current with industry best practices, regulatory updates, and technological advancements to ensure the eTMF system remains state-of-the-art.
• Continuous Improvement:
  • Identify opportunities for enhancing eTMF processes and system functionality, driving continuous improvement initiatives to enhance efficiency and compliance.
  • Stay up to date with industry trends, regulatory changes, and technological advancements to keep the eTMF system and processes at the forefront of best practices.
  • Participate in eTMF configuration as a subject matter expert.
• Audit and Inspection Support:
  • Prepare for and support internal and external audits and regulatory inspections, ensuring that the eTMF is ready and compliant.
  • Address and resolve any findings related to eTMF during audits or inspections, implementing corrective actions where necessary.
• Company culture:
  • Comfortable multi-tasking in a fast-paced small company start-up environment and able to adjust workload based upon changing priorities. Adaptable / flexible, self-starter (willing and able to adjust to multiple demands, sometimes beyond job descriptions and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
  • Excellent team player but also independently without significant oversight
  • Strong Self-Starter and hardworking individual, willingness and ability to fill functional gaps in a small organization.

Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, or a related field. Equivalent work experience may be considered.
• 7+ years of experience in clinical trial document management, with at least 3-5 years of experience specifically in managing eTMF systems.
• Extensive experience with Veeva Vault eTMF or similar eTMF systems, including system implementation and ongoing management.
• Proven track record of developing and executing eTMF strategies in a GCP-compliant environment.
• Experience with GxP system implementation, configuration, validation, and maintenance preferred.
• Experience developing TMF related SOPs, templates, plans, and tools.
• Regulatory authority inspection experience a plus 
• Experience managing multiple studies
• Experience managing complex or global trials preferred familiarity with regulatory process in global studies
• Ability to travel as necessary (approximately 10 – 15 %)
• Deep understanding of ICH-GCP guidelines, FDA regulations, and global regulatory requirements related to clinical trial documentation.
• Strong leadership and project management skills, with the ability to lead cross-functional teams and drive change.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced environment.
• Strong communication and interpersonal skills, with the ability to influence and collaborate across all levels of the organization.
• Experience in a biotech or pharmaceutical startup environment.
• Certification in clinical trial management or document management.
• Experience in preparing for and supporting regulatory audits and inspections.
• Effective oral, written and interpersonal communication skills.
• Strong communication skills
• Sop development preferred
• Strong organizational and project management skill and the ability to multitask
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project) 
• Oncology Therapeutic Experience required
• Excellent working knowledge GCP, FDA and ICH Guidelines

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