Regional Study Start Up Lead
Core
Lead regional site activation and study start-up for clinical trials across European countries, ensuring timely activation and regulatory compliance.
Role type
Senior IC clinical trial study start-up lead (regional)
Builds
Clinical trial sites and study activation packages for European markets
Domain
Clinical trials / Life sciences
Required skills
EUCTR submission expertise, regional study start-up management, site selection, regulatory document review (ICF), project management, cross-functional team coordination, risk mitigation, CTMS/eTMF/Veeva/Microsoft Project proficiency
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; act as SME for EUCTR submissions; manage EC and regulatory authority payments; coordinate SSU specialists; serve as escalation point for regulatory/vendor issues; monitor project status and risks; facilitate knowledge transfer across countries; oversee EC submission strategies and ICF management; provide quality checks for submission packages; ensure operational readiness (binders, supplies, training); coordinate information flow and sign-offs; manage amendment implementations
Seniority
Senior, hands-on IC
