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The Yale New Haven Hospital Center for Outcomes Research and Evaluation (CORE) is a leading national outcomes research center dedicated to transforming healthcare for the betterment of people and society by leveraging data, analytics, and technology. We have assembled a talented, multidisciplinary group who are committed to developing solutions to the practical needs of medicine and healthcare. Our organization combines the highest academic ideals with a pragmatic approach that emphasizes the production of useful knowledge. We are distinguished by our creativity, dedication, experience, and skills, and our commitment to having our work make a tangible difference to patients, the public, and society. For additional information on CORE, please visit our website: www.medicine.yale.edu/core.
Under the direction of the Associate Director of Operations (CORE), the Senior Manager for Computational Health/Data Sciences position is responsible for overseeing general operations within the CORE Center for Computational Health (CCH). The individual will work in a team environment to coordinate activity, develop and implement validation plans for clinical predictive models, review data and findings from analytic experiments, and assist with the coordination of staff researchers and trainees in the organization.
Responsibilities: 1. Project Coordination / Management: 1) Coordinate tasks between Yale and Yale New Haven Health employees working on collaborative projects; 2) Develop technical implementation plans; 3) Assist with creation of technical architecture and documentation; 4) Work with vendors to maintain schedule of renewals, upgrades, and evaluation of potential new products. 2. Model Development: 1) Assist in the development of clinical predictive models, with a focus on the identification and selection of clinically-meaningful real-world data; 2) Works closely with researchers in CCH and with collaborators to aid in the technical planning for development of clinical models and software applications; 3) Review regulatory needs and requirements with analysts and researchers interested in implementing clinical analytic models. 3. Validation Planning: 1) Develop validation plans for clinical analytic models based on requirements for FDA/CMS validation of medical devices and in vitro diagnostics (including laboratory-developed tests); 2) Work with internal groups and vendors to assure documentation of model validation is appropriate and routinely reviewed. 4. Staff Integration and Communication: 1) Works closely with analysts, physicians, and researchers to identify and create necessary documentation and implementation plans to facilitate completion of projects; 2) Creates and maintains regular status reports; 3) Promotes a team atmosphere that is conducive to the overall accomplishment of goals, schedules, and deadlines; 4) Openly shares information with all team members; 5) Organizes regular staff meetings to facilitate communication among data scientists in the group. 5. Process Documentation: 1) Assists with creation of implementation and deployment plans; 2) Documents and maintains repository of validation plans and results for clinical analytic models
*This position is co-terminus with funding.
Bachelors degree required with a preference in the areas of healthcare management, clinical laboratory sciences, or healthcare information technology. Masters or masters level coursework preferred.
Minimum of seven years of experience in healthcare management, preferably in a role involving direct responsibility for regulatory preparedness and accountability. Prior experience with the creation and management of validation materials for medical devices, including in vitro diagnostics, is required. Budgetary experience and experience with supply vendors and interaction with contract specialists is desired.
Strong background in healthcare and healthcare management. Experience with developing validation plans for the FDA, CMS, and/or CAP, specifically within medical devices and in vitro diagnostics, including laboratory-developed tests (LDTs). Working knowledge of healthcare information technology, specifically electronic health records (EHRs) and laboratory information systems (LIS). Prior experience in healthcare data analysis and test validation. Prior management/supervisory experience required. The ability to simultaneously manage diverse projects is required. The ability to effectively communicate with clinicians in various disciplines is required. MS Office skills including Word, Excel, and PowerPoint required.
Responsible to the Associate Director of Operations (CORE) for all aspects of project management, clinical model validation, and regulatory readiness. Working in conjunction with the Director, researchers, and data scientists, coordinates activities and facilitates projects to effectively drive projects to completion and to clinical utility.
Regularly exercises independent judgement in the performance of all duties and responsibilities. Must be able to handle multiple projects concurrently. Makes recommendations for the development and improvement of departmental systems.