Regional Study Start‑Up Lead

About the role

The Regional Study Start‑Up Lead will manage site activation across European countries, ensuring timelines and quality standards are met. This role requires deep EUCTR knowledge and hands‑on start‑up experience within the European region, working from the Baar office three days a week.

Key responsibilities

• Lead day‑to‑day management of multiple site activation projects or a multi‑study program.
• Drive site selection processes, oversee activation timelines, and ensure compliance with EUCTR part 2 documentation.
• Coordinate SSU specialists, act as escalation point for regulatory and vendor issues, and monitor project status and risks.
• Provide quality checks for EC submission packages, informed consent forms, and essential document packages.
• Ensure operational readiness of sites, including binders, lab kits, training, and system access.

Required profile

• Minimum 8 years of clinical trial experience, with at least 5 years in study start‑up and 3 years at a regional level.
• Previous experience in a CRO and strong EUCTR submission background.
• Proven project‑management and site‑activation expertise in the European region.
• Excellent communication, organizational, and leadership skills in English.

Required skills

• Strong EUCTR experience.
• Proficiency with CTMS, eTMF, Veeva, and Microsoft Project.