Clinical Trial Manager

reputed company 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 reputed company the reputed company 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. reputed company 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 reputed company; join us in helping to revolutionize precision heartcare. reputed company 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 reputed company and management of reputed company clinical operational activities at the trial and site level. The CTM will interact well with the reputed company Clinical Research staff and collaborate effectively with reputed company 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 reputed company the department and cross functionally, including SOP development Conducts study start-up activities including the development of protocols, informed consent forms, reputed company 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 reputed company other duties as required for successfully completing studies, as necessary Skills Needed: Ability to work in a smaller team environment with a willing, reputed company 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 reputed company office tools including Word, reputed company and PowerPoint Educational Requirements & Work Experience: Bachelor’s degree in science or health reputed company 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 reputed company salary compensation range is $95,000 to $125,000 and cash bonus. #LI-Remote. reputed company is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects reputed company individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national reputed company, reputed company, 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 reputed company, including recruitment, hiring, training, relocation, promotion, and termination. Positions posted for reputed company 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. reputed company has become aware of a fraud where unknown entities are posing as reputed company 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 reputed company parties, please verify the following: A) reputed company legitimate reputed company recruiter email addresses end with “@reputed company.com” and B) the position described is reputed company on our careers site at www.reputed company.com/about/careers/. Apply To This Job