Associate Director eTMF

Associate Director eTMF Department: Clinical Operations Employment Type: Full Time Location: Cambridge, MA Description Join our mission to close in on cancer. We are seeking an Associate Director for our electronic Trial Master File (eTMF) team. This role involves leading the eTMF team and overseeing the management of all eTMF activities, ensuring that the Trial Master File is inspection-ready at all times. Key Responsibilities As Associate Director eTMF you we acting as TMF Subject Matter Expert for the clinical study team and supporting cross-functional departments to ensure high quality documentation. Oversee and manage the setup and ongoing review of studies within the Veeva system, acting as a Veeva Vault Expert. Be responsible for the set-up, management and archiving processes and execution of Vault including naming conventions and processes, migrations etc. Ensure the TMF is compliant and ready for inspections by auditors and regulatory authorities. Lead the development of procedural documents, TMF management plans, and related materials. Act as a point of contact for project teams, CROs, auditors, IT and external parties. Review and resolve discrepancies within eTMFs, ensuring timely reporting and internal reviews. Participate in clinical operations meetings, audits, and inspection readiness activities. Identify and implement process improvements in collaboration with stakeholders. Manage the budget proposals from third parties related to eTMF activities or systems. Lead and direct staff to ensure documentation activities comply with GCP, SOPs, and regulatory requirements. Oversee access management and ensure appropriate internal and external access to the eTMF system. Be a complete system owner and expert for Veeva Vault at Merus. Ensure compliance with global regulations and guidelines for TMF management. Your profile: The ideal candidate will have extensive experience with Veeva Quality systems and will be responsible for training and supervising eTMF staff. Bachelor's degree or international equivalent in information management, library science, clinical science, or a related field. 7-9 years of TMF management experience in global clinical trials. Experience with computerized clinical trial records management technologies, particularly Veeva systems. 3-5 years of personnel management experience. Strong organizational, writing, and communication skills. Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements. Our offer : We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part or Merus, you'll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours and a company bonus structure. Most importantly, you'll have the chance to help us close in on cancer - everything you do matters at Merus. This position can be based either in the US or Europe.

Created: 2024-10-19