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/
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.
Since its founding in 1701, Yale University has been dedicated to expanding and sharing knowledge, inspiring innovation, and preserving cultural and scientific information for future generations. Yale’s reach is both local and international. It partners with its hometown of New Haven, Connecticut to strengthen the city’s community and economy. And it engages with people and institutions across the globe in the quest to promote cultural understanding, improve the human condition, delve more deeply into the secrets of the universe, and train the next generation of world leaders.
Yale offers exciting opportunities for achievement and growth in New Haven, Connecticut. Conveniently located between Boston and New York, New Haven is the creative capital of Connecticut with cultural resources that include three major museums, a critically-acclaimed repertory theater, state-of-the-art concert hall, and world-renowned schools of Architecture, Art, Drama, and Music.
We invite you to discover the excitement, diversity, rewards and excellence of a career at Yale University. One of the country's great workplaces, Yale University offers exciting opportunities for meaningful accomplishment... and true growth. Our benefits package is among the best anywhere, with a wide variety of insurance choices, liberal paid time off, fantastic family and educational benefits, a variety of retirement benefits, extensive recreational facilities, and much more.