Regional Study Start-Up Lead
Core
Lead regional site activation and study start-up operations for clinical trials across European countries, ensuring timely site selection, regulatory submissions, and operational readiness.
Role type
Senior IC study start-up lead (clinical trials)
Builds
Clinical trial site activation and regulatory compliance
Domain
Life sciences / Clinical research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site activation management, EUCTR submissions, ICF review, regulatory document review, project management, cross-functional team coordination, risk mitigation, amendment implementation, operational readiness planning, stakeholder communication
Preferred skills
Regional regulatory process knowledge, advanced clinical trial management tracker proficiency
Technologies
CTMS, eTMF, Veeva, Microsoft Project
Responsibilities
Lead day-to-day management of multi-study site activation programs; drive site selection processes; oversee site activation timelines and quality standards; act as SME for EUCTR submissions; manage EC and regulatory authority payments; coordinate SSU specialists; monitor project status and risks; facilitate knowledge transfer across countries; oversee EC submission strategies and document quality; ensure operational readiness including site binders and training; manage amendment implementation
Seniority
Senior, hands-on IC
