Clinical Research Study Manager

at  Cardiosense

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.
About the role:
We are seeking an experienced and highly motivated Clinical Research Study
Manager to oversee the planning, execution, and completion of clinical research
projects. The Clinical Research Study Manager will be responsible for leading
cross-functional teams to ensure that studies are conducted in compliance with
regulatory requirements and guidelines, including Good Clinical Practice (GCP)
guidelines

QUALIFICATIONS:

• Bachelor’s degree in a health-related field or relevant work experience in clinical research.
• 5+ years of experience in clinical research project management or related field.
• 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.
• Willingness to learn and take on new challenges.
  This is a full-time position based in Chicago, IL that may require occasional evening or weekend work. The Clinical Research Study Manager will report to the Director, Clinical Research 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.

• Lead the planning, execution, and oversight of 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.
• Track and report on study progress, including enrollment, data collection, and data management.Prepare study reports, presentations, and publications.
• Ensure that studies are conducted in compliance with regulatory requirements and guidelines, including GCP guidelines.
• Develop and maintain relationships with key stakeholders, including study coordinators, investigators, and sponsor representatives.