GenesisCare

Manager

• Lead and manage the Clinical Safety function, providing strategic, operational, and people leadership to ensure a high-performing, compliant, and inspection-ready safety department.
• Oversee end-to-end safety operations across clinical trials, including SAE and SUSAR management, medical review coordination, regulatory and ethics reporting, and ongoing safety oversight.
• Maintain oversight and ownership of the safety database, including study setup, data quality, system configuration, and ensuring the system remains compliant with regulatory and business requirements.
• Act as the primary point of accountability for safety governance, audit and inspection readiness, and safety-related Trial Master File (TMF) quality and compliance.
• Partner closely with Clinical Project Managers, Medical Monitors, and Sponsors to embed safety oversight into study delivery, risk management, and decision-making.
• Lead or act as Project Manager for safety-only projects and Sponsor engagements, ensuring delivery to scope, timelines, and regulatory expectations.
• Drive continuous improvement of safety processes, systems, and team capability within a lean CRO environment.

Clinical Safety Manager