Clinical Project Manager A

Clinical Project Manager AThe 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 comfortable holding several protocols at once. Contingent upon funding.