Clinical Trial Manager

Posted 19 Hours Ago
2 Locations
Remote
Senior level
Healthtech
Transforming Cardiovascular Care Through Innovation
The Role
The Clinical Trial Manager at HeartFlow is responsible for overseeing clinical trial operations, managing study sites, and ensuring regulatory compliance. They will develop clinical trial timelines, manage vendors, and lead process improvements while maintaining effective relationships with investigators and coordinators to uphold study quality and timelines.
Summary Generated by Built In

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

Heartflow is a VC-backed company that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 400,000 patients worldwide.  

The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the HeartFlow Clinical Research staff and collaborate effectively with HeartFlow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture. #LI-IB1; #LI-Remote

Job Responsibilities:

  • 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

Skills Needed:

  • 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

Educational Requirements & Work Experience:

  • 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%

A reasonable estimate of the base salary compensation range is $95,000 to $140,000 (for San Francisco Bay Area) and $85,000 to $115,500 (for all areas outside of San Francisco Bay Area), cash bonus, and stock options.

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.

 

Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.

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The Company
Austin, TX
650 Employees
On-site Workplace
Year Founded: 2010

What We Do

Heartflow is the global leader in AI-driven coronary artery disease (CAD) management, transforming how CAD — the world’s leading cause of death — is diagnosed and treated. Our advanced technology generates personalized, precision 3D heart models from a single CT scan, providing clinicians with the clarity and confidence to deliver earlier, more effective treatments — transforming CAD into a disease that can be managed for life.

Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications.

With over 400,000 patients treated, more than 1,400 leading institutions adopting our solution, and 99.5% of U.S. lives covered — Heartflow is redefining the standard of coronary care. We're a global company, with employees across the United States, Europe and Japan. Our headquarters are in Mountain View, California, with additional offices in California, Texas, the UK, and Japan.

We believe CAD shouldn’t be a silent threat. By making it screenable, diagnosable, and manageable, we’re changing the story of CAD, empowering clinicians to save lives and giving patients more time for what matters most.

Why Work With Us

Join Us to Rewrite the Story of CAD.

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