Role overview

Qualifications

Bachelor's degree in science or health related field
Demonstrated 5 years minimum relevant experience required
Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
Experience in cardiovascular medical device clinical research a plus

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
Participates in and leads process improvement activities within the department and cross functionally
Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.

Key facts

Remote from: Illinois (USA), Minnesota (USA), Texas (USA)
Full time
Senior (5-10 years)
English

Hard skills

Clinical Trial Management Systems Regulatory Compliance Project Management Clinical Research Coordination Vendor Management ICH Guidelines FDA Regulations Cardiac Devices

Other skills

Detail Oriented
Microsoft Office
Communication
Teamwork
Organizational Skills
Multitasking
Problem Solving

About the company

HeartFlow, Inc

Medical Devices & Equipment

HeartFlow is a medical technology company transforming the way cardiovascular disease is diagnosed and treated. With our HeartFlow Analysis, a non-invasive personalized cardiac test, physicians are able to make better care decisions for their patients with suspected coronary artery disease--the number one killer of men and women worldwide. HeartFlow is backed by decades of scientific research and development and leverages the latest advancements in technology to help set a new standard of care for diagnosing cardiovascular care worldwide. Cleared for use in the United States, Canada, Europe and Japan and with offices in Redwood City, Austin, London and Japan, HeartFlow’s footprint is growing rapidly. HeartFlow has received more than $240 million dollars in funding in a recent Series E financing round, is pre-IPO and leverages the latest technology including deep learning and computational fluid dynamics. We try to embody the best of both technology and healthcare companies and hire people who are passionate about living our mission to save lives, improve the patient experience and reduce the overall cost of care. For more information, visit www.heartflow.com.

Company details

Company typeSME

IndustryMedical Devices & Equipment

Company size201 - 500

Links

Website LinkedIn See all jobs

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

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 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 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 500,000 patients worldwide.

This position is open for the Central Midwest region, with targeted cities but not limited to: Chicago, Illinois; Minneapolis, Minnesota; Dallas, Texas; Houston, Texas; Austin, Texas.

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.

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 $125,000 and cash bonus. #LI-Remote.

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/.