For companies:
For professionals:
For everyone:
Responsibilities
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 FFRCT 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 (FFRCT 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.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 agement of study documentation, vendor management, and completion of project management tasksDevelops clinical trial timelines, enrollment projections, and instructional materials luding project, communication, monitoring, recruitment, risk mitigation, and contingency plansParticipates luding 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 el 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 $125,000 and cash bonus.*
Closes in:
0
days
0
hours
0
min
0
sec
tune NOT FOR YOU? IMPROVE YOUR RESULTS