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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. Used by over 500,000 patients globally and cleared in the US, UK, Europe, Japan, and Canada, HeartFlow is transforming precision cardiac care.
The Clinical Trial Manager will oversee all clinical operational activities across multiple trial sites on the East Coast, including Philadelphia, New York, New Jersey, Pittsburgh, Atlanta, Washington DC, Orlando, Fairfax, and Boston. This role bridges HeartFlow's clinical research team with site coordinators, principal investigators, and 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 materials); reviewing regulatory documents for GCP compliance; and maintaining relationships with investigators, research 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. A bachelor's degree in science or health-related field is required. The role demands strong organizational skills, meticulous attention to detail, knowledge of ICH Guidelines and FDA/European regulations, and proficiency in Microsoft Office. Comfort with shifting priorities, multi-tasking, and a collaborative startup mindset are essential. Travel up to 25% is required across the East Coast region.
