Keya Mukherjee

Lead and manage end-to-end operational support for project/study delivery activities, ensuring adherence to ICH GCP guidelines and GSK control documents. Oversee risk management, vendor performance, and audit readiness.

Collaborated with study leads for effective planning and implementation of clinical studies. Managed budgets, enrollment forecasts, and vendor onboarding while ensuring smooth trial workflows.

Led project planning, scheduling, cost control, and risk management for clinical trials. Prepared budgets, managed vendor invoices, and performed critical path analysis.

Led and trained a team, established goals and provided performance feedback. Prepared monthly metrics and updated eTMF documents for sponsor monitored countries.

Supported feasibility team on investigator/site identification and patient recruitment planning. Enabled regulatory database searches for audit findings and due diligence checks.

Streamlined day-to-day activities by identifying and resolving issues. Created and maintained team process documents and SLAs, and prepared monthly metrics for client requirements.

Master of Science in Biotechnology from Maharani Lakshmi Ammani College for Women, Bangalore University, India.

Bachelor of Science in Microbiology, Chemistry, and Botany from Vijaygarh Jyotish Ray College, University of Calcutta, India.

Post Graduate Certification in Clinical Research and Clinical Data Management from Bioinformatics Centre, University of Pune, India.