Clinical Project Manager A

University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Project Manager A Job Profile Title Clinical Research Project Manager A Job Description Summary The Clinical Project Manager A will manage the operational and regulatory conduct of a portfolio of interventional neuromodulation trials. The group studies low-intensity focused ultrasound and deep brain stimulation for obsessive-compulsive disorder and substance use disorder, with funding from the National Institutes of Health (NIMH and NIDA) and philanthropic sources. Studies are conducted at Penn with a collaborating academic site and an industry device partner, and are carried out under investigator-held abbreviated Investigational Device Exemptions with FDA record-keeping and safety-reporting obligations. Under guidance from the Principal Investigator, the Clinical Project Manager manages day-to-day operations of the clinical research projects, maintains the studies’ regulatory files, and serves as the principal operational point of contact with the collaborating site, the device manufacturers and the Data and Safety Monitoring Board. The role assists with protocol development, project coordination across sites, and quality control of data; supports grant applications and NIH progress and milestone reporting; prepares reports and presentations; contributes to dissemination of study findings; and may supervise project staff and participate in study visits. This position suits someone who wants breadth across regulatory affairs, trial operations and cross-institutional coordination on first-in-population device research, and who is…