The Manager will lead the Case Review Board process for global clinical trials, coordinating meetings and managing imaging workflows. They will also provide leadership to junior team members and collaborate with cross-functional stakeholders to ensure efficient patient screening and trial execution.
Responsible for the preparation and submission of global regulatory documentation for medical devices, including clinical and post-market applications. Collaborates with cross-functional teams to ensure regulatory strategy alignment and manages ongoing compliance with regulatory bodies and standards.
Lead and develop a clinical data management team while building the function's infrastructure from the ground up. Oversee end-to-end data management for active trials, ensuring data integrity and submission readiness in partnership with Clinical Operations and Biostatistics.
