About Our Client
- World leading Medical Device / Health Technology company with a focus on innovation and patient care
- Global company with a passionate, collaborative and diverse team
Responsible for team's interface and collaboration with Key Opinion Leaders(KOLs) and management.
Lead clinical scientific discussions with PMDA, including proposed clinical investigations.
Lead the confirmation for clinical data, study results, and essential documents for the clinical data package, and lead the regulatory inspection by PMDA
Develop, revise and maintain study design and outlines, scientific rationale, Protocol Synopsis and full protocol of the local clinical studies/CIS/PMS.
Lead to implement study protocol including knowledge transfer to clinical operation team, execution of clinical study oversight of clinical studies/CIS/PMS in Japan, and also to prepare for the following documents as applicable
Lead to execute medical monitoring while conducting independent clinical study in Japan (Local study).
Lead to develop Clinical Study Report (CSR) of the Local study, relevant parts of Summary of Technical Documents (STED), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.
The Successful Applicant
What's on Offer