Manages clinical trial operations across multiple study sites and protocols. Leads a team of CRAs and ensures site monitoring quality and compliance. Reviews monitoring visit reports and escalates critical findings appropriately. Manages CRO relationships and oversees third-party clinical operations. Develops site management plans, monitoring plans, and risk-based monitoring strategies. Coordinates with data management and biostatistics teams for data review. Ensures timely submission of clinical study reports and regulatory filings. Manages study budgets, site payments, and milestone tracking systems. Leads inspection readiness programs for regulatory authority audits. Prepares and delivers training for CRAs on protocols and GCP compliance. Manages trial master file completeness and archival for completed studies. Supports business development by reviewing clinical feasibility for new studies. Stays current with adaptive trial designs, CDSCO regulations, and GCP updates.