Senior Clinical Study Manager
Core
Manage operational delivery of Phase 3 clinical trials and Phase 4 post-approval studies for rare diseases, ensuring delivery to agreed timelines, budgets, and regulatory compliance.
Role type
Senior Clinical Study Manager (Phase 3 & 4)
Builds
Clinical studies for rare disease treatments
Domain
Biopharmaceuticals / Rare Diseases / Clinical Operations
Required skills
Clinical operations leadership, Phase 3 study management, rare disease/pediatric study experience, post-approval study management, CRO/vendor oversight, budget management, eTMF maintenance, ICH-GCP/FDA/MHRA/EMA regulatory knowledge, project management
Preferred skills
FDA Bioresearch Monitoring inspection familiarity, hybrid/decentralized trial approaches, international travel
Technologies
eTMF systems
Responsibilities
Lead feasibility, country and site selection; coordinate clinical supply planning and adaptive design decision points; oversee regulatory and ethics submissions and audit support; manage study budgets and vendor performance; mentor clinical operations colleagues