Clinical Trial Manager

Clinical Trial Manager - East CoastHeartflow 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 (RoadMap™Analysis), 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 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.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 tasksDevelops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plansParticipates in and leads process improvement activities within the department and cross functionally, including SOP developmentConducts 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 GCPsMaintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data managementPerform other duties as required for successfully completing studies, as necessarySkills Needed:Ability to work in a smaller team environment with a willing, all hands on deck attitudeAbility to manage multiple tasks and be comfortable working in an environment with shifting prioritiesHigh attention to detail, accuracy, and quality and able to effectively prioritize multiple projectsKnowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulationsExcellent written and oral English communication skills requiredProficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPointEducational Requirements & Work Experience:Bachelor's degree in science or health related fieldDemonstrated 5 years minimum relevant experience requiredExperience in cardiovascular medical device clinical research a plusTravel required: up to 25%A reasonable estimate of the base salary compensation range is $95,000 to $130,000 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.