Your responsibilities
As our Head of Clinical Operations, you would be responsible for overseeing the management of our study operations within cAIre, our AI-powered Image Reading Center supporting clinical studies in retinal diseases. This role is pivotal to the smooth execution of clinical and research study protocols, ensuring compliance with timelines, regulatory requirements, and quality standards. The Head of Clinical Operations provides leadership to the Study Managers, drives operational excellence, and partners cross-functionally to enable successful study operations.
- Lead end-to-end clinical study execution, ensuring delivery against protocol, timelines, quality standards, and client expectations
- Drive protocol development and optimization in collaboration with sponsors, clinical teams and CMO
- Oversee resource planning, balancing multiple concurrent studies and ensuring the team fully prepared for upcoming demands
- Champion cross-functional collaboration, coordinating seamlessly with cAIre project manager, readers, data analysts and external stakeholders to achieve study milestones
- Ensure regulatory compliance and data integrity, upholding GCP, HIPAA, 21 CFR Part 11, and implementing robust quality-control processes for imaging workflows
- Enhance operational excellence, optimizing study workflows, integrating advanced technologies (e.g., AI-driven image analysis), and proactively managing risks
- Lead, mentor, and develop the Study Managers, fostering a high-performance culture supported by training programs and clear KPIs for continuous improvement