Clinical Trial Manager - Central Midwest New Chicago, Illinois, United States; Dallas, Texas; H[...]

HeartFlow, Inc.; Illinois; On-site; USD 95,000 - 125,000; Full time

Job summary

A medical technology firm is seeking a Clinical Trial Manager to oversee clinical studies focused on coronary artery disease. The role requires at least 5 years of experience, a bachelor's degree in a health-related field, and a deep understanding of clinical trial processes. This position offers a competitive salary range of $95,000 to $125,000, along with cash bonuses.

Qualifications

• 5+ years of relevant experience required.
• Experience in cardiovascular medical device clinical research a plus.

Responsibilities

• Oversee and manage clinical operational activities.
• Interact with clinical research staff and vendors.
• Develop clinical trial timelines and enrollment projections.
• Conduct study start-up activities.

Skills

Team collaboration

Multi-task management

Attention to detail

Knowledge of ICH Guidelines

Excellent communication

Proficiency in Microsoft Office

Education

Bachelor’s degree in science or health related field

Job description

Overview

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 CT 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 (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.

Role and Responsibilities

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.

• 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 and Qualifications

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.

Equal Opportunity and Important Notices

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.

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.