Clinical Trial Manager - Investigator Initiated Studies

Clinical Trial Manager - Investigator Initiated Studies

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 productan AI-driven, non-invasive cardiac test supported by the ACC / AHA Chest Pain Guidelines called the Heartflow FFR CT Analysisprovides 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 (RoadMapAnalysis), assess coronary blood flow (FFR CT 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 publicly traded company (HTFL) 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.

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 leading study kick off meetings, contract management, and site onboarding and training.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) as needed 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.
• Tracks internal and external project deliverables to ensure they remain within the timeline and budget.
• Performs other duties as required for successfully completing studies, as necessary.

Skills Needed

Educational Requirements & Work Experience :

A reasonable estimate of the base salary compensation range is $110,000 to $150,000 (for San Francisco Bay Area) and cash bonus.

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.

Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following : A) all legitimate Heartflow recruiter email addresses end with "@heartflow.com" and B) the position described is found on our careers site at www.heartflow.com / about / careers / .