Scientist - 総合研究所 臨床医学研究室
Core
Conduct clinical trials and clinical development for Abbott's in vitro diagnostic pharmaceuticals in Japan to achieve regulatory approval, managing data acquisition, analysis, and reporting.
Role type
Clinical Scientist (In Vitro Diagnostics)
Builds
Clinical trial data and regulatory submissions for in vitro diagnostic products
Domain
Healthcare / In Vitro Diagnostics / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and execution, Data analysis and reporting, Regulatory compliance knowledge, Laboratory safety protocols, Cross-functional communication, GxP quality systems management
Preferred skills
Experience with prototype reagent development, Post-market surveillance planning
Technologies
Clinical trial management systems, Laboratory information management systems
Responsibilities
Plan and execute clinical trials for in vitro diagnostic products in Japan, Collaborate with physicians and clinical laboratory scientists to advance trial progress, Create and maintain quality assurance systems for clinical development, Ensure compliance with Japanese regulatory requirements and conduct audits, Develop and revise clinical development procedures for new products
Seniority
Mid-Senior, hands-on IC
