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Assistant Director of Clinical Data Management
Yale University
| The Yale School of Medicine and Yale Center for Clinical Investigation (YCCI) is expanding its clinical research administration and clinical trials operations team. There are currently several exciting opportunities to join our staff and help direct Yale’s clinical research enterprise as it continues to grow. The Yale School of Medicine oversee thousands of studies annually. YCCI is the administrative hub for Yale’s Clinical and Translational Science Award (CTSA), providing support for research across Yale University, Yale Medicine, and the Yale New Haven Health System, which includes one of the largest hospitals in the nation. For more information please visit https://medicine.yale.edu/ycci/about/job-opportunities/
General Purpose: Lead all Clinical Data Management (CDM) activities for YCCI multi-site studies under the leadership of the Sr. Associate Director of Systems and Project Management.
Provide CDM expertise for multiple multi-site projects to meet the needs of clinical research studies, including overseeing data standards development, validation activities, monitoring project timelines, and communicating with stakeholders. Supervise, train, mentor, and develop Data Management team to build skills and meet client expectations. Supervise and approve creation of database specifications and Electronic Data Capture (EDC) Case Report Form study builds. Develop, implement, and maintain libraries to support both industry and YCCI internal data standards (CDISC SDTM, ADaM, define.xml). Work collaboratively with internal and external teams to implement eSource data projects (e.g. integration of EHR and other external data sources). Identify opportunities to build process efficiencies and increase data quality.
As an integral member of the multi-center clinical trials project team for clinical research, the position ensures an environment that promotes quality research management and facilitates interdisciplinary research activities. The Senior Clinical Data Management Project Manager further promotes a compliant culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including coordinating initiatives which identify, prevent, and appropriately mitigate multisite trials and FDA Part 11 research system compliance risk, and ensure that YSM, YM, YNHH compliance efforts align with the university’s broader compliance strategy and framework. The position coordinates effectively with other units/departments within the university such as Project Management (YCCI), Biostats (YCAS), and EHR research team (JDAT); clinical trials sponsors and vendors; and with research teams at other academic centers. Familiar with a variety of the field's concepts, practices, and procedures and relies on experience and judgment to plan and accomplish goals. This position may require remote work on either a regular or temporary, part-time or full-time basis.
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