Data Manager
Lindus HealthFull Time
Mid-level (3 to 4 years)
Candidates must have demonstrated experience managing different types of data for clinical trials, possess exceptional organizational skills, and exhibit excellent attention to detail. They should be comfortable working in a fast-paced start-up culture and have knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations. The ability to manage multiple tasks with shifting priorities, high attention to detail, accuracy, and quality, and flexibility to learn new techniques are also essential.
The Clinical Data Associate is responsible for the oversight and management of all clinical data activities for clinical trials, including developing timelines for data management, enrollment projections, and creating instructional materials. They will oversee the development and user acceptance testing of clinical databases, upload cases, and enter biometrics. Responsibilities also include participating in process improvement activities, SOP development, assisting with study start-up, examining and resolving data inconsistencies, and maintaining relationships with investigators, site coordinators, and vendors. The CDA will act as the point of contact for data management in study meetings and may travel for investigator meetings or vendor visits.
Non-invasive cardiac testing for heart disease
HeartFlow provides a non-invasive cardiac test that helps visualize a patient's coronary arteries in detail. This technology allows physicians to diagnose and treat heart disease more effectively without the need for invasive procedures, which reduces risks for patients and costs for healthcare providers. HeartFlow's main clients are healthcare professionals seeking safer diagnostic methods. The company offers several analyses, including FFRCT Analysis and Plaque Analysis, all of which have received FDA clearance and are available in multiple countries, including the United States, the United Kingdom, Japan, and Canada. Unlike many competitors, HeartFlow focuses on providing a comprehensive suite of analyses that enhance treatment planning. The goal of HeartFlow is to improve cardiovascular care by making it safer and more efficient for both patients and healthcare providers.