Country Study Start Up Specialist
Core
Coordinate ethics submissions, documentation, and site activation to move clinical studies from planning to active sites in Australia.
Role type
Senior IC clinical study start-up specialist
Builds
Active clinical trial sites for new medicines
Domain
Healthcare / Clinical Research
Required skills
Clinical research experience, Study start-up management, Regulatory submissions, Ethics/IRB coordination, Site activation, Risk assessment, ICH/GCP guidelines knowledge, Data management (Vault SSU), KPI tracking
Preferred skills
Remote team collaboration, Process improvement, Adverse event reporting, Country/site intelligence database management
Technologies
Vault SSU, IXRS, ALCOA compliance tools
Responsibilities
Establish country/site activation plans and risk mitigation strategies; Compile and submit ethics and local regulatory submissions; Coordinate with Regulatory Affairs and Contract Managers for timely site activation; Review site/IRB comments on informed consent forms; Trigger clinical supply and IP shipments; Maintain SSU performance metrics and KPIs; Ensure audit/inspection readiness; Report adverse events within 24 hours.
Seniority
Mid-level, hands-on IC
