Tania Gupta

Clinical research professional and licensed Dentist with 7+ years of progressive experience in Risk-Based Central Monitoring (RBM) and Integrated Quality Risk Management (IQRM) across global Phase I–III trials. Proven record of designing and executing centralized monitoring strategies, developing Risk Assessment & Mitigation Plans (RAMP), and leading cross-functional teams to ensure patient safety, data integrity, and regulatory compliance. Adept at risk signal detection, data analytics, and statistical monitoring using spotfire and advanced Excel. Recognized for audit/inspection readiness, mentoring teams, and driving process improvements in highly complex, multi-country studies.

• Managed oversight for 20+ clinical trials across 200+ sites and 12,000+ subjects, ensuring end-to-end site monitoring, operational compliance, and quality deliverables.
• Led a team as CML for an accelerated COVID vaccine trial, completing system set-up and start-up within 45 days and recruitment/enrolment within 30 days; recognized with the CEO Team of the Year award.
• Serve as SME and trainer for new hires, IJPs, and refresher sessions on risk-based monitoring, effective query management, EAC, and site payments; additionally act as QCer for review plans to maintain quality and compliance.