The Clinical Data Associate (CDA) is responsible for the oversight and management of all clinical data activities for a variety of different clinical trials and data associated with these trials. The CDA 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 ensure clinical studies meet or exceed timelines and maintain high quality standards. The CDA will have demonstrated experience managing different kinds of data for clinical trials, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast-paced start-up culture. This position will be remote with a preference to be based within driving distance of the Mountain View, CA office unless otherwise agreed upon. #LI-IB1

Job Responsibilities:

• Manages project deliverables to ensure they remain within the timeline and budget
• Develops timelines for data management activities, enrollment projections, and creates/modifies/reviews instructional materials in support of trial execution, including project and data management plans
• Oversees the development of any clinical database by the EDC/CRO vendor, and will manage the sponsor user acceptance testing of the clinical database
• Upload cases and enter biometrics for assigned clinical studies, as required
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development
• Works with other clinical research team members on study start-up activities including the development and review of case report forms, source document worksheets, training presentations, etc.
• Examines and resolves data inconsistencies within specified timelines that may be urgent in nature
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs, consultants, and CROs
• Works in coordination with statisticians, programmer/analysts, clinical research team members, and other team members as required
• Acts as point of contact for data management in all meetings relating to a study
• Perform other duties as required for successfully completing studies, as necessary
• Some travel may be required; may occasionally attend investigator meetings, or vendor visits/audits

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
• Flexibility and willingness to learn new techniques and procedures to ensure the successful completion of 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; SAS a plus; Python a plus

Educational Requirements & Work Experience:

• Bachelor’s degree in science or health related field
• Demonstrated 2-4 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus
• Experience in registry studies and investigator-initiated studies a plus

A reasonable estimate of the yearly base compensation range is $80,000 to $110,000, cash bonus, and stock options.