Clinical Trial Manager

Job not on LinkedIn

September 27

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Logo of HeartFlow, Inc

HeartFlow, Inc

Healthcare Insurance • Artificial Intelligence • Science

HeartFlow, Inc. is a company pioneering in the field of cardiovascular diagnostics and care, utilizing advanced medical imaging and artificial intelligence. It offers a non-invasive personalized cardiac test that provides visualization of coronary arteries, allowing physicians to develop effective treatment plans for heart disease, which is the leading cause of death. HeartFlow’s technology combines human expertise and AI-powered tools to offer physicians critical insights without the need for invasive procedures, thus enhancing safety and efficiency in cardiovascular care. The company's solutions, such as the FFR CT Analysis, are widely adopted among top hospitals, delivering accurate and timely assessments of heart health.

📋 Description

• Oversight and management of all clinical operational activities at the trial and site level • Interact with Heartflow Clinical Research staff and collaborate with onsite and field staff, clinical research coordinators, principal investigators, and vendors • Develop clinical trial timelines, enrollment projections, instructional materials, and project, communication, monitoring, recruitment, risk mitigation, and contingency plans • Participate in and lead process improvement activities, including SOP development • Conduct study start-up activities including development of protocols, informed consent forms, source document worksheets, and training presentations • Review site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs • Maintain 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

🎯 Requirements

• 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 and able to effectively prioritize multiple projects • Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations • Excellent written and oral English communication skills required • Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint • Bachelor’s degree in science or health related field • Demonstrated 5 years minimum relevant experience required • Experience in cardiovascular medical device clinical research a plus • Travel required: up to 25%

🏖️ Benefits

• cash bonus

Apply Now

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