Clinical Trial Manager - Midwest

Overview

Clinical Trial Manager - Central Midwest rtflow is a medical technology company advancing diagnosis and management of coronary artery disease using AI-driven, non-invasive cardiac testing. The flagship Heartflow FFRCT Analysis provides a color-coded, 3D model of a patient’s coronary arteries to indicate the impact of blockages on blood flow and supports clinicians across the CCTA pathway.

Heartflow is publicly traded (HTFL) and has been used for more than 400,000 patients worldwide. The Clinical Trial Manager (CTM) is responsible for oversight and management of all clinical operational activities at the trial and site level, collaborating with Heartflow Clinical Research staff, onsite and field staff, clinical research coordinators, principal investigators, and vendors to ensure studies meet timelines and maintain high quality standards.

• 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
• Performs 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 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 Microsoft Office tools (Word, Excel, PowerPoint)

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

Travel: up to 25%

Salary: a base salary range of $95,000 to $125,000 and cash bonus is referenced as a reasonable estimate.

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of 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 every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.