Uma Mageshwari

About Uma Mageshwari

Experience in Clinical Data Management with strong knowledge of data management activities Worked in therapeutic areas of Respiratory, Cardiovascular, Endocrinology, Oncology and Rare Disease across all clinical phases from phase 1 to phase 4Skilled in different EDC databases RAVE, Inform, Open Clinica, Trail master, Veeva vault and other sponsor specific systemsGood knowledge in Global data standards, Drug Development and ICH - Good Clinical Practice (GCP)Experience in Study start up task - Protocol review, preparing e-CRF and Edit check specification, Performing database UAT, worked on other systems (Endpoint- IXRS, RSG) integration UAT Study conduct - Query management, Data validation, Protocol deviation review, Listings review, SAE reconciliation, Third party vendor reconciliation, IXRS reconciliation and PRO reconciliation etc. Good knowledge in creation of specs for customized review reports (medical review reports, patient profile report and study specific reports) and Data management metrics reports (CPT, Missing Pages Report and Data subset reports)Study Close out - Documentation as per requirements, database closeout activities. Archiving all study documents post database lock Good knowledge in creation of data management documents (DMP, DRP and CCG.etc)Strong project management skills, managing different stakeholders Mentoring lead data managers, coaching the new team members and interns, DM oversight, perform Quality management of projects Managing a team as a line manager, interviewed new hires, experience in performance management and appraisal reviewPlanning resourcing, creating KPI dashboard reports for the project portfolio

Experience

1. Manager

   Fortrea

   Jun 2024 — Present · Bengaluru, IN

Education

• Vinayaka Mission's Research Foundation - University

  BE, Bioinformatics

  2008 — 2012