Clinical Research Spec
Core
Ensuring safety and reliability of clinical trials and post-marketing studies for medical devices in Japan, optimizing trial environments through facility management and strong relationships with medical institutions.
Role type
Senior Clinical Research Specialist (Medical Device)
Builds
Clinical trials and post-marketing studies for medical devices
Domain
Medical Devices / Clinical Research
Deliverable
client delivery
Required skills
GCP knowledge, medical device company or CRO monitoring experience (5+ years), hospital management experience, English document reading and reporting, adverse event reporting, regulatory compliance
Preferred skills
Cardiovascular domain experience, team leadership, junior monitor mentoring, KOL management, ISO 14155 knowledge
Technologies
None stated
Responsibilities
Plan, execute, and manage progress of clinical trials and post-marketing studies; conduct facility procedures, monitoring, and audits; create and review related documents; report and respond to serious adverse events and deviations; report medical device malfunctions
Seniority
Senior, hands-on IC