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About the Role

Heartflow is seeking a Clinical Trial Manager to oversee and manage all clinical operational activities at the trial and site level. This role involves collaborating with internal teams, external partners, and ensuring clinical studies meet timelines and quality standards within a fast-paced startup culture.

Responsibilities

• Manage clinical study sites, documentation, and vendors, completing project management tasks.
• Develop clinical trial timelines, enrollment projections, and instructional materials.
• Lead process improvement activities and SOP development.
• Conduct study start-up activities, including protocol and informed consent form development.
• Review site regulatory documents for compliance with study requirements and GCPs.
• Maintain effective working relationships with investigators, research coordinators, and vendors.
• Perform other duties as required for successful study completion.

Requirements

• Demonstrated experience with clinical research study execution.
• Exceptional organizational skills.
• Excellent attention to detail.
• Comfortable working in a fast-paced start-up culture.
• Ability to work in a smaller team environment with a willing, all hands on deck attitude.
• Ability to manage multiple tasks and be comfortable working in an environment with 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 programs, specifically Microsoft Office (Word, Excel, PowerPoint).

Skills

• Clinical research study execution
• Organizational skills
• Attention to detail
• Teamwork
• Task management
• Prioritization
• ICH Guidelines
• US FDA regulations
• European clinical trial regulations
• Written communication
• Oral communication
• Microsoft Office Suite

Location

• Central Midwest region (Chicago, Illinois; Minneapolis, Minnesota; Dallas, Texas; Houston, Texas; Austin, Texas)

Work Type

• Remote
• Full-time

Experience Level

• 5 years minimum relevant experience

Education Level

• Bachelor’s degree in science or health related field

Salary/Compensations

• $95,000 to $125,000
• Cash bonus

About the Company

• Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven, non-invasive cardiac testing.
• The flagship product, Heartflow FFRCT Analysis, provides a 3D model of coronary arteries to assess the impact of blockages on blood flow.
• Heartflow offers an integrated heart care solution across the CCTA pathway, including RoadMap™ Analysis, FFRCT Analysis, and Plaque Analysis.
• Heartflow is a publicly traded company (HTFL) recognized for healthcare innovation.
• The product is cleared for use in the US, UK, Europe, Japan, and Canada, and has been used for over 500,000 patients worldwide.

Equal Opportunity

• Heartflow is an Equal Opportunity Employer committed to a work environment that supports, inspires, and respects all individuals.
• Discrimination is prohibited based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
• This policy applies to all aspects of employment, including recruitment, hiring, training, relocation, promotion, and termination.