SSU Specialist

This role supports the day-to-day operations of assigned activities within the Study Start-Up (SSU) function to ensure timely completion of drug and non-drug program goals in compliance with GCP/ICH guidelines. The position involves overseeing site-level activities from potential site list receipt through activation, managing essential document preparation, and facilitating ICF negotiations and IMP release packages. The specialist will also generate project status and financial information, proactively escalate issues, and maintain accurate data in clinical systems.