Senior Specialist, Country Study Start Up
Core
Lead study start-up strategy and accelerate activation of new medicines for patients in Australia.
Role type
Senior Manager, Clinical Study Start-Up
Builds
Clinical study activation and maintenance across assigned sites and studies
Domain
Healthcare / Clinical Research
Required skills
Clinical research regulations interpretation, IRB/EC submission management, cross-functional stakeholder coordination, risk assessment and mitigation, process improvement leadership, data quality management (ALCOA), clinical supply and IP release coordination, performance metrics tracking, training and mentoring
Preferred skills
Experience with Vault SSU platform, remote team collaboration, ICH and GCP guidelines knowledge, change management adoption
Technologies
Vault SSU, IXRS
Responsibilities
Establish country/site activation plans and priorities, identify and resolve risks impacting delivery, compile and submit ethics submissions, coordinate regulatory and contract activities for site activation, trigger clinical supply and IP shipments, activate sites in IXRS, maintain local intelligence databases, drive process improvement initiatives, mentor Country Start-Up Specialists
Seniority
Senior, hands-on IC with mentorship responsibilities
