Shovan Saha serves as Associate Director of Clinical Data Management at Daiichi Sankyo with over 18 years of comprehensive clinical trial experience spanning the complete lifecycle from study startup through database lock activities. Specializing in oncology for 14+ years, he has served as Lead Data Manager and Program Clinical Data Manager for five FDA-submitted and approved cancer treatments across breast cancer, hepatocellular carcinoma, melanoma, pancreatic neuroendocrine tumors, and tuberous sclerosis complex. His expertise encompasses Phase I-IV studies with particular strength in Phase III pivotal trials that achieved regulatory approval. Shovan demonstrates technical proficiency across multiple Clinical Data Management Systems including Oracle Clinical, Oracle RDC, Inform, Rave, Clintrail, and PHOSCO, complemented by expertise in data visualization platforms such as Spotfire, ICRS, and J-Review.
With 12+ years successfully managing international CRO relationships, he currently leads multidisciplinary teams of 4-6 staff while providing strategic oversight for complex global initiatives including electronic SAE reporting system implementation and safety database integration. He previously held the Certified Clinical Data Manager (CCDM) designation from SCDM and earned his Master of Science in Biotechnology from Bangalore University. Currently, Shovan is advancing multiple antibody-drug conjugate (ADC) treatment projects across non-small cell lung, gastric, prostate, and breast cancers toward regulatory approval, maintaining the highest standards of data integrity and regulatory compliance throughout the drug development process.