Clinical Trial Manager @ HeartFlow

HeartFlow, Inc. 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 FFR_CTAnalysis—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 (FFR_CTAnalysis), 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, pre-IPO 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 250,000 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-Remote; #LI-IB1

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 3-5 years minimum relevant experience required
Experience in cardiovascular medical device clinical research a plus
Experience in investigator-initiated studies preferred

A reasonable estimate of the base salary compensation range is $95,000 to $135,000 (for San Francisco Bay Area) and $85,000 to $110,500 (for all areas outside of San Francisco Bay Area), cash bonus, and stock options.

HeartFlow, Inc. 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.

US Locations Only: All employees and contingent workers (contractor, consultant, interns or temporary personnel) are required to be vaccinated against SARS-CoV-2 as recommended by CDC, unless a reasonable accommodation is approved. All prospective hires will be expected to provide proof of vaccination on their first day of employment.

Compensation Overview

Job Responsibilities:

Skills Needed:

Educational Requirements & Work Experience:

6 month growth

1 year growth

2 year growth