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/
As an integral member of the multi-center clinical trials project management team for clinical research, the position ensures an environment that promotes quality research management and facilitates interdisciplinary research activities. The Sr. Clinical Trials 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 coordinate 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 biostats (YCAS), EHR research team (JDAT), Human Subjects Protections (HRPP), industry contracting team, and finance; 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.
Required Education and Experience:
Bachelor’s Degree in a related field and five years of related work experience or equivalent combination of education and experience.
Previous experience working as a Project Manager for an industry Sponsor or CRO managing FDA and/or EMA regulated clinical trials. Extensive experience in all facets of study start-up/activation, external site feasibility, participant enrollment, on-going management of multiple-external sites and protocols, study close-out, and regulatory submission.
Experience in clinical trial management for FDA regulated industry-sponsored clinical trials, or an equivalent combination of education and experience.
Extensive knowledge of federal and state regulations protecting human subjects involved in research, demonstrated by five or more years of experience in an organization leadership position.
Comprehensive technical knowledge of FDA and EMA clinical trial regulations.
Professionalism, maturity, good judgment, and the ability to work with confidential material. The ability to work remotely; including an adequate workspace with internet access.
Preferred Education and Experience: Master's degree strongly preferred. 7 years of clinical trials experience as a Project Manager for an industry Sponsor or CRO strongly preferred. Experience in clinical management systems is preferred. Experience implementing Electronic Health Record studies.
Application: For more information and immediate consideration, please apply online at https://bit.ly/YaleCareers-63651BR. Please be sure to reference this website when applying for this position.
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.
Yale University considers applicants for employment without regard to and does not discriminate on the basis of an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression.
Internal Number: 63651BR
About Yale University
Yale University 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.