> 26 years of experience
Expertise: Clinical Research; Data Management, Clinical Programming and Statistics, Data Standards governance and Implementation, Safety & Risk Management along with transition and process management across broad Therapeutic Areas and Clinical Trial Phases. Strong experience in Biosimilars, Real World Studies//Data & Risk Based Monitoring.
Experience in large global projects/deployments and clinical study transitions for Clinical Trials, Data Management & Safety/Pharmacovigilance operations for major international pharmaceuticals across multiple geographies & Platforms.
Strong experience in setting up large teams ; outcome based global clinical programs, extensive knowledge of clinical research, ICG GCP, Quality Assurance, Partner /Vendor management.
>17 years of domain experience
Expertise: Linear, non-linear statistical modelling, adaptive trial designs and Risk based monitoring
Experience in multiple BA/BE, early phase and late phase trials in therapeutic area's like Oncology, Endocrinology, respiratory, vaccines and has rich experience in IVIVC and Population Pharmacokinetic modelling.
Various publications to his credit
>18 years of experience
Expertise: Clinical Research; Data Management, Clinical Programming and Statistics, Data Standards governance and Implementation, Safety & Risk Management along with transition and process management across broad Therapeutic Areas and Clinical Trial Phases.
Experience in Clinical Research domain across Pharmaceutical, CRO and BPO industry under the areas of Clinical Data Management, Project Management and Team Management.
Strong experience in setting up an offshore Clinical Data Management unit for a Global Pharmaceutical company with end-to-end Clinical Data Management activities. Strong understanding of cross functional Clinical Data Management activities, project initiation, planning and ongoing project management skills. Strong understanding of Operations Management, project commercials, project metrics and Quality Assurance in Clinical Data Management.
