Regulatory & Start Up Specialist 2, cFSP
Core
End-to-end site management from feasibility to closure, serving as the primary contact for investigative sites and supporting regulatory submissions and site activation/maintenance.
Role type
Senior Regulatory & Start Up Specialist (Clinical Research)
Builds
Activated and maintained clinical study sites across assigned countries
Domain
Biopharmaceuticals / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Site qualification, regulatory green light, site close-outs, EC submission management, import/export license acquisition, radiation board approvals, biobank committee approvals, contract negotiation, study team coordination, document collection and tracking, country/site intelligence gathering
Preferred skills
In-house model process document development, Veeva Vault proficiency, Microsoft Office proficiency, independent work, proactive issue resolution, multi-tasking
Technologies
Veeva Vault, Microsoft Office
Responsibilities
Participate in development of in-house model process documents; serve as primary site contact for end-to-end study activity; participate in study site management meetings; track activities and produce reports; oversee document collection and review; support Ethics Committee and Regulatory Authority submissions; complete and manage country/site-specific regulatory activities (licenses, board approvals)
Seniority
Senior, hands-on IC
