Clinical Trial Manager

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 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 #J-18808-Ljbffr