• Responsible for the monitoring and oversight of clinical trial sites conducting cell therapy clinical studies in compliance with protocol, ICH-GCP, applicable regulatory requirements, and company SOPs. • Ensure site qualification, initiation, routine monitoring, and close-out visits are performed in accordance with monitoring plans and study timelines. • Verify informed consent process and documentation for all study participants. • Conduct source data verification (SDV) and source data review (SDR) to ensure data accuracy and completeness. • Review and resolve data queries in collaboration with sites and data management. • Monitor chain of identity (COI) and chain of custody (COC) processes related to cell collection, manufacturing, shipping, and administration. • Ensure timely and accurate reporting of adverse events (AEs, SAEs), and special safety events per protocol and regulatory requirements. • Support inspection readiness activities and participate in regulatory inspections or audits as needed. • Serve as the primary point of contact for assigned clinical trial sites.