Clinical Study (Project) Manager (CRMS @ Tokyo)
Core
Leading clinical teams to execute pre-market and post-market clinical studies for new medical devices, ensuring regulatory approval and collecting safety/efficacy data.
Role type
Senior Clinical Study Manager (Project Lead)
Builds
Clinical trial execution plans, regulatory submissions to PMDA, and post-market evidence packages for medical devices.
Domain
Medical Devices / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
J-GCP/ISO14155 compliance, external supplier (CRO/SMO) management, project management, regulatory negotiation, data collection/management, budget planning, device management
Preferred skills
Medical field experience (nurse/pharmacist), PMDA GCP inspection experience, CRA experience, statistical analysis, data management
Technologies
EDC, paper CRFs, internal clinical systems
Responsibilities
Develop clinical study plans and execution documents; negotiate study progress with PMDA and investigators; manage external suppliers and site agreements; oversee milestones and budget; manage investigational devices; conduct data analysis and publication; handle regulatory reporting and audits
Seniority
Senior, hands-on IC