ACADEMIC QUALIFICATIONS

BSc: Poona College of Pharmacy, Pune

PROFILE SUMMARY

Clinical Data Management Expert with over 30 years of experience in Data Operations within the Global Pharma and Outsourcing Industry. Her career has been marked by leadership positions in Clinical Research encompassing Data Management, Statistical Programming, Artificial Intelligence /ML and Pharmacovigilance Operations.

CONSULTING EXPERIENCE

3 years

EXPERIENCE HIGHLIGHTS

Sciformix

Director, Clinical DevelopmentDirector, Clinical Development
SciformixSciformix
Sep 2015 - Aug 2018 · 3 yrsSep 2015 - Aug 2018 · 3 yrs
Mumbai Area, IndiaMumbai Area, India
Expertise in Data Operations in Global Clinical Trials .End to End Clinical and Post Marketing studies for Global & Indian Customers. Strong & prior experience in leadership roles in Clinical Data Management, Statistical Programming & Pharmacovigilance operations.

Cognizant Technology Solutions
An Early Adopter of Clinical Data Management Outsourcing to India with 22 years of experience in Pharmaceutical industry and 15 years experience in Clinical Research: Data Management and Pharmacovigilance.

Managed large Safety teams (~650 FTEs) in India and Latin America for case processing & Aggregate reporting for Top 5 innovator company

Strong knowledge and expertise in Clinical Data Management and Pharmacovigilance operations along with transition and process management across broad Therapeutic Areas and Trial Phases.

Successfully led and supported large projects/deployments and study transitions for Data Management operations for major international pharmaceuticals across multiple geographies & Platforms.

Extensive experience in data processing, CRF design, database administration and validation, data monitoring, safety monitoring and operations.

Developed appropriate staff skill sets to deliver quality clinical trial data, and to facilitate success within the function through increasing management and team leadership capabilities.

Successfully established and managed the STP (SOPs, training and Processes function) at global top 5 pharmaceutical. Additionally, set up similar function at Cognizant for Training, Quality and compliance and audits.

Developed and successfully implemented concept of Quality Management Program for multiple work streams including data management, Statistical Programming & Analysis, Medical writing and Pharmacovigilance.

Actively involved in process improvement & re-engineering initiatives at organization and practice level in various areas like data management, Programming, Pharmacovigilance.

Core member in reviewing and implementing data management related process improvements (Six sigma projects) across multiple processes process Experience in leading Training, Transaction quality and Quality Assurance for large CDM , PV and life sciences engagements.

Pfizer Pharmaceuticals
Managed Training and SOPs for Development Operations at Pfizer. Involved in process improvement and operational excellence initiatives in clinical data management area.
Managed multi geography data management projects across various therapeutic areas