Carly Stein is a Senior Clinical Trials Project Manager in the Center for Cellular Immunotherapy at the University of Pennsylvania, where she manages the sponsor operations of CAR T cell therapy clinical trials. Carly independently manages multiple Phase I-Phase II Penn-Sponsored clinical research studies in order to ensure execution of clinical research and oversee clinical studies from concept to final close, including study start-up activities, study monitoring activities, data collection, project maintenance and project close-out activities. She is responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines and other applicable regulations. Carly is responsible for the overall execution of the project and acts as the principal liaison to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues. Carly combines a Master in Regulatory Affairs degree from Penn Perelman School of Medicine, a Master in Law degree from Penn Carey Law School, a benchwork research background, and a thorough understanding of clinical trials operations to bring a unique perspective to the workplace.