Regulatory & Start Up Specialist 1 - Sponsor Dedicated
Core
Country-level Site Activation Specialist ensuring regulatory compliance and document readiness for clinical studies.
Role type
Senior IC Regulatory & Start Up Specialist
Builds
Regulatory documents, Investigator Packs, and ethics approvals for clinical sites
Domain
Clinical research / Life sciences
Required skills
Site activation management, regulatory document preparation, quality control, project timeline planning, stakeholder coordination, data tracking, contingency planning
Preferred skills
Direct sponsor contact experience, complex issue evaluation, multi-priority management
Technologies
Internal systems, databases, tracking tools
Responsibilities
Serve as Single Point of Contact for assigned studies, perform start-up and site activation activities, prepare and review site regulatory documents, maintain internal databases, track document approval and execution, provide local expertise to project teams, perform quality control of site documents
Seniority
Junior to Mid-level, hands-on IC
