Clinical Study Manager - Medical Devices
hace 2 días
Paris
Clinical Manager – Europe - Cardiac Medical Device study Based in France (ideally Paris area) Permanent opportunity Key Responsibilities • Oversee study setup, site selection, ethics submissions, budgets, timelines, monitoring, and reporting., • Manage CROs, core labs, and clinical vendors, ensuring quality, compliance, and on-time delivery., • Supervise CRAs and clinical staff, providing leadership and performance support., • Ensure compliance with ICH-GCP, ISO 14155, EU MDR, and local European regulations., • Support regulatory submissions, audits, and inspection readiness., • Collaborate cross-functionally with R&D, Regulatory, Quality, Marketing, and Medical Affairs teams., • Manage study budgets, forecasts, and operational milestones. Skills/Experience required: • Multiyear experience clinical research (of which at least 3 years have been spent managing Cardiology clinical trials), • Life Science Degree background, • Strong knowledge of European clinical trial regulations., • Happy to travel across Europe to clinical sites., • CE-marking and EU MDR clinical evidence experience., • Having an additional European languages would be beneficial.