Edwards Lifesciences Spec, Clinical Science (Tokyo) in Tokyo, Japan
Ensure Edwards clinical study device documentation provides a valid source of device traceability and accountability data for regulatory submissions, reporting, and audits.
• Lead in the investigation of all discrepancies by applying clinical protocol knowledge and develop processes to minimize possibility of recurrence
• Lead in assessing current process, identifying opportunities and implementing solutions to improve process efficiency within and across related functional areas
• Conduct in house and site (if applicable) reviews of associated documentation and lead in internal and Japan agency audits to ensure documents are compliant with Good Documentation Practices, Edwards internal SOPs, and Japan regulations
• Resolve basic remote queries closures within electronic databases
• Analyze local clinical trial results and develop report for inclusion in the submission to PMDA
• Assess informed consent form (ICF) and collaborate with site (e.g., study coordinator) to ensure ICF includes all Japan regulations and EW requirements
• Provide coaching and training to lower level employees
• Other incidental duties
2years or above monitoring expewience
Understanding of Japanese law related to clinical trial
Bachelor degree of science
Business level English
Native level Japanese
Documentation experience (Clinical trial protocol etc)
Clinical science experience
Experience of global clinical trial
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.