cardiosense, Inc.
Director, Clinical Research
cardiosense, Inc., Chicago, Illinois, United States, 60290
Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.We are seeking a highly experienced and motivated Director, Clinical Research, to oversee the planning, execution, and completion of complex clinical research projects. The Director will be responsible for managing the clinical research operations team and ensuring that studies are conducted in compliance with regulatory requirements and guidelines, including Good Clinical Practice (GCP) guidelines.
Key Responsibilities:
Lead the clinical research operations team to ensure the appropriate planning, execution, and oversight of complex clinical research projects, including coordinating the activities of cross-functional teams, ensuring compliance with protocols and standard operating procedures, and monitoring progress against project timelines and budgets.Develop and review study-related documents, such as protocols, informed consent forms, case report forms, and study manuals.Lead study start-up activities, including site identification, feasibility assessment, and study initiation visits.Manage study vendors, including clinical research organizations (CROs) and other external service providers, to ensure that services are provided in a timely and cost-effective manner.Manage study monitors and provide guidance and support as needed.Develop and maintain relationships with key stakeholders, including study coordinators, investigators, and sponsor representatives.Ensure that studies are conducted in compliance with regulatory requirements and guidelines, including GCP guidelines.Manage study budgets and timelines, including forecasting and tracking expenses and negotiating study contracts.Develop risk management plans and mitigation strategies.Develop and implement quality control measures to ensure the accuracy and completeness of study data.Prepare study reports and presentations.Mentor and train junior staff members.Requirements:
Bachelor's degree in a health-related field or relevant work experience in clinical research.10+ years of experience in clinical research project management or related field, with a proven track record of managing complex clinical research projects.In-depth knowledge of regulatory requirements and Good Clinical Practice (GCP) guidelines.Excellent organizational, communication, and problem-solving skills, with the ability to prioritize and multitask effectively.Strong attention to detail and accuracy.Proficiency with Microsoft Office Suite and experience with electronic data capture systems.Ability to lead cross-functional teams and work effectively in a fast-paced, deadline-driven environment.Experience with clinical trial budgets and financial management.Strong leadership skills, with proven experience in managing clinical research teams including direct reports.Willingness to learn and take on new challenges.Travel, approx. 20-30% at times.
Director, Clinical Research, will report to the VP of Clinical and Scientific Affairs and work closely with the entire clinical research team.Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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Key Responsibilities:
Lead the clinical research operations team to ensure the appropriate planning, execution, and oversight of complex clinical research projects, including coordinating the activities of cross-functional teams, ensuring compliance with protocols and standard operating procedures, and monitoring progress against project timelines and budgets.Develop and review study-related documents, such as protocols, informed consent forms, case report forms, and study manuals.Lead study start-up activities, including site identification, feasibility assessment, and study initiation visits.Manage study vendors, including clinical research organizations (CROs) and other external service providers, to ensure that services are provided in a timely and cost-effective manner.Manage study monitors and provide guidance and support as needed.Develop and maintain relationships with key stakeholders, including study coordinators, investigators, and sponsor representatives.Ensure that studies are conducted in compliance with regulatory requirements and guidelines, including GCP guidelines.Manage study budgets and timelines, including forecasting and tracking expenses and negotiating study contracts.Develop risk management plans and mitigation strategies.Develop and implement quality control measures to ensure the accuracy and completeness of study data.Prepare study reports and presentations.Mentor and train junior staff members.Requirements:
Bachelor's degree in a health-related field or relevant work experience in clinical research.10+ years of experience in clinical research project management or related field, with a proven track record of managing complex clinical research projects.In-depth knowledge of regulatory requirements and Good Clinical Practice (GCP) guidelines.Excellent organizational, communication, and problem-solving skills, with the ability to prioritize and multitask effectively.Strong attention to detail and accuracy.Proficiency with Microsoft Office Suite and experience with electronic data capture systems.Ability to lead cross-functional teams and work effectively in a fast-paced, deadline-driven environment.Experience with clinical trial budgets and financial management.Strong leadership skills, with proven experience in managing clinical research teams including direct reports.Willingness to learn and take on new challenges.Travel, approx. 20-30% at times.
Director, Clinical Research, will report to the VP of Clinical and Scientific Affairs and work closely with the entire clinical research team.Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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