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Salary: USD 90,000 - 130,000 / 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, supported by ACC/AHA guidelines. Used by over 500,000 patients globally and cleared in the US, UK, Europe, Japan, and Canada, HeartFlow is revolutionizing precision cardiac care.
The Clinical Trial Manager for Investigator Initiated Studies will oversee all clinical operational activities for investigator-initiated research programs. This role requires managing clinical study sites, coordinating study documentation, vendor relationships, and ensuring timelines and quality standards are met. The position involves close collaboration with HeartFlow's clinical research team, field staff, clinical research coordinators, principal investigators, and external vendors.
Key responsibilities include: developing clinical trial timelines and enrollment projections; creating instructional materials and project management plans; leading study kick-off meetings and site onboarding; managing contracts and regulatory documentation review (informed consents, IRB approvals); maintaining stakeholder relationships; tracking deliverables against timeline and budget; and driving process improvement initiatives including SOP development.
The ideal candidate brings 5+ years of clinical research experience, preferably with investigator-initiated studies and cardiovascular medical device background. Required qualifications include a bachelor's degree in science or health-related field, knowledge of ICH Guidelines and FDA/European regulations, strong organizational skills, attention to detail, and proficiency with Microsoft Office tools. The role demands comfort in a fast-paced, startup-culture environment with ability to manage multiple priorities and shifting deadlines.
