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Salary: USD 95,000 - 125,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship product, HeartFlow FFR_CT Analysis, is a non-invasive cardiac test that provides 3D visualization of coronary arteries and blood flow assessment. Cleared for use in the US, UK, Europe, Japan, and Canada, the platform has been used for over 500,000 patients worldwide.
The Clinical Trial Manager will oversee all clinical operational activities across trial sites in the East Coast region (Philadelphia, New York, New Jersey, Pittsburgh, and Atlanta). This role bridges HeartFlow's clinical research team with site coordinators, principal investigators, and external vendors to ensure studies meet timelines and quality standards.
Key responsibilities include: managing clinical study sites and documentation; developing trial timelines, enrollment projections, and instructional materials; leading process improvement and SOP development; conducting study start-up activities (protocols, informed consent forms, training); reviewing regulatory documents for GCP compliance; and maintaining relationships with investigators, coordinators, and vendors including core labs and data management.
The ideal candidate has 5+ years of clinical research experience, preferably in cardiovascular medical device trials. Required skills include knowledge of ICH Guidelines, US FDA, and European clinical trial regulations; strong project management and organizational abilities; proficiency with Microsoft Office; and excellent communication skills. A Bachelor's degree in science or health-related field is required. Up to 25% travel is expected.
