Medical Device, Clinical Lead
Lead Evidence Generation Strategy from Clinical Development Perspective
Contribute to the Development and Approval of Lifechanging Medical Devices
- Pioneering global medical device company with expertise in orthopedics, surgery, interventional solutions and vision care
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:
- Investigator's Brochure (IB) - Japanese translated version
- Case Report Form (CRF)
- FAQ on patient eligibility or other medical issues and potential concerns
- Safety management plan, if any
- Statistical Analysis Plan (SAP)
- Analytical risk based monitoring plan
- Related other documents to clinical studies
- Training materials for clinical operation team involved and investigators
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.
- Extensive experience in clinical development of medical devices
- Expertise in ICH, GCP and related regulations
- High level of communication skills
- Business level English (reading, writing, speaking)
- Fluent level of Japanese
- Opportunity to contribute to clinical development of medical device at a high level