Temp Global Site Start Up Lead
Core
Driving global execution of site activation for clinical trials, ensuring efficient and compliant processes aligned with Regeneron SOPs and ICH-GCP guidelines.
Role type
Senior IC clinical trial site start-up lead
Builds
Global site activation strategies and country start-up plans for clinical studies
Domain
Biopharmaceuticals / Clinical Research
Required skills
Site activation strategy development, CRO performance monitoring, risk mitigation, regulatory submission coordination, TMF management, country intelligence analysis, milestone tracking
Preferred skills
Fast-track initiation expertise, cross-functional team leadership, process improvement, data-driven site selection
Technologies
Trial Master File (TMF), Central Institutional Review Boards (CIRBs), Local Institutional Review Board (LIRB) systems
Responsibilities
Develop site start-up strategies and country start-up plans; monitor and analyze CRO performance; lead site activation activities including document collection and milestone tracking; support regulatory submissions and IRB processes; serve as subject matter expert for site documentation; represent SSU on cross-functional teams.
Seniority
Senior, hands-on IC