Heartflow
Clinical Trial Manager - Central Midwest
Heartflow, Minneapolis, Minnesota, United States, 55400
Clinical Trial Manager - Central Midwest
Join to apply for the
Clinical Trial Manager - Central Midwest
role at Heartflow Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, using cutting-edge technology. The flagship product provides an AI-driven, non-invasive cardiac test to help clinicians identify stenoses, assess coronary blood flow, and quantify atherosclerosis. Heartflow is a publicly traded company (HTFL) with a global presence and a history of medical innovation. Responsibilities
Participate in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks Develop clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans Participate in and lead process improvement activities within the department and cross-functionally, including SOP development Conduct study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc. Review site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs Maintain 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 & Qualifications
Ability to work in a smaller team environment with an all-hands-on-deck attitude Ability to manage multiple tasks and adapt to shifting priorities High attention to detail, accuracy, and quality with strong prioritization Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations Excellent written and oral English communication skills Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) Educational Requirements & Experience
Bachelor’s degree in science or health-related field Minimum 5 years of relevant experience Experience in cardiovascular medical device clinical research is a plus Travel required: up to 25% Salary range: $95,000 to $125,000 with cash bonus (base salary estimate) Heartflow is an Equal Opportunity Employer. We are committed to a work environment that respects all individuals and do not discriminate against any employee or applicant for protected characteristics. This policy applies to all aspects of employment. Positions posted for Heartflow are not intended for or open to third party recruiters/agencies. Submission of unsolicited resumes will be considered free referrals. Before providing personal information, verify legitimate Heartflow recruiter emails end with @heartflow.com and that the position is listed on the Heartflow careers site.
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Join to apply for the
Clinical Trial Manager - Central Midwest
role at Heartflow Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, using cutting-edge technology. The flagship product provides an AI-driven, non-invasive cardiac test to help clinicians identify stenoses, assess coronary blood flow, and quantify atherosclerosis. Heartflow is a publicly traded company (HTFL) with a global presence and a history of medical innovation. Responsibilities
Participate in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks Develop clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans Participate in and lead process improvement activities within the department and cross-functionally, including SOP development Conduct study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc. Review site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs Maintain 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 & Qualifications
Ability to work in a smaller team environment with an all-hands-on-deck attitude Ability to manage multiple tasks and adapt to shifting priorities High attention to detail, accuracy, and quality with strong prioritization Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations Excellent written and oral English communication skills Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) Educational Requirements & Experience
Bachelor’s degree in science or health-related field Minimum 5 years of relevant experience Experience in cardiovascular medical device clinical research is a plus Travel required: up to 25% Salary range: $95,000 to $125,000 with cash bonus (base salary estimate) Heartflow is an Equal Opportunity Employer. We are committed to a work environment that respects all individuals and do not discriminate against any employee or applicant for protected characteristics. This policy applies to all aspects of employment. Positions posted for Heartflow are not intended for or open to third party recruiters/agencies. Submission of unsolicited resumes will be considered free referrals. Before providing personal information, verify legitimate Heartflow recruiter emails end with @heartflow.com and that the position is listed on the Heartflow careers site.
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