SSO Study Start-Up Manager
Core
Leads study start-up activities for clinical trials in Japan, ensuring compliance with GCP/ICH and local regulations to achieve Green Light status for medical sites.
Role type
Senior clinical study start-up manager
Builds
Clinical trial start-up deliverables and site readiness
Domain
Clinical pharmaceutical development
Required skills
Clinical trial project management, Regulatory compliance (GCP/ICH), IRB/IEC submission management, Medical site selection, Team leadership, Process improvement
Preferred skills
Feasibility analysis, Vendor management, Budget management, Waterfall model planning
Technologies
GCP, ICH, IRB/IEC, TMF, SOP
Responsibilities
Lead domestic study start-up strategy and schedule achievement; Prepare and review regulatory submission documents for IRB/IEC; Manage domestic study start-up team activities and meetings; Ensure compliance with financial and regulatory standards; Coordinate with global study teams and Feasibility Managers; Drive medical site selection and patient enrollment planning.
Seniority
Senior, hands-on IC with leadership capabilities