Clinical Trial Manager - West Coast

Overview

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, using AI-driven technology. Our flagship product—the Heartflow FFR CT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries to indicate the impact of blockages on blood flow. Heartflow offers an integrated heart care solution across the CCTA pathway, helping clinicians identify stenoses, assess coronary blood flow, and quantify coronary atherosclerosis.

Our pipeline of products is growing and so is our team.

Heartflow is a publicly traded company (HTFL) with recognition for healthcare innovation, supported by medical societies worldwide, cleared for use in the US, UK, Europe, Japan and Canada, and used for more than 400,000 patients worldwide.

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• Perform other duties as required for successfully completing studies, as necessary

• Ability to work in a smaller team environment with an all-hands-on-deck attitude
• Ability to manage multiple tasks and adapt to shifting priorities
• High attention to detail, accuracy, and quality with the ability to prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills
• Proficiency in computer software, including Microsoft Word, Excel and Power Point

• Bachelor’s degree in science or health-related field
• Demonstrated 5 years minimum relevant experience
• Experience in cardiovascular medical device clinical research is a plus

Travel required:

up to 25%

Salary range: $110,000 to $150,000 base, plus potential cash bonus (San Francisco Bay Area).

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under law.