- Lead Evidence Generation Strategy from Clinical Development Perspective
- Contribute to the Development and Approval of Lifechanging Medical Devices
About Our Client
- Expanding global Medical Device company with expertise in Cardiovascular, Neuro, Orthopedic areas
Responsible for team's interface and collaboration with Key Opinion Leaders(KOLs) and management.
- Line management of members of Clinical Affairs department
Lead clinical 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, 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.
The Successful Applicant
- Strong experience in clinical trial area
- Capable of conceptualizing and overseeing broad range of clinical trial activities
- Expertise in ICH, GCP and related regulations
- High level of communication skills
- Business level English (reading, writing, speaking)
- Fluent level of Japanese
What's on Offer
- Opportunity to contribute to an expanding international medical device company
- Lead team of clinical trial professionals and support building of this organization in Japan