Smita Gupte

Associate Director Functional Lead at Novartis

Andhra Pradesh, India

About

Experience

  • Novartis India (13 yrs)
    • Associate Director Functional Lead
      Sep 2022 - Present · 3 yrs 10 mos

    • Senior Prinicipal Clinical Data Manager
      Apr 2019 - Sep 2022 · 3 yrs 6 mos

    • Prinicpal Clinical Data Manager
      Apr 2018 - Mar 2019 · 1 yr

  • Clinical Data Associate-II at INC Research
    Apr 2012 - Jul 2013 · 1 yr 4 mos

  • Clinical Data Associate I at Kendle International
    Jul 2010 - Mar 2012 · 1 yr 9 mos

  • Jr. Clinical Programmer at Lambda Therapeutic Research Ltd.
    Apr 2007 - Jun 2010 · 3 yrs 3 mos

     Database designing using Clintrial 4.5.  Writing SQL rules and derivations for Clinical Trials.  Annotation of CRF.  Preparation of Data Management Plan, Validation Plan and Edit checks.  Testing Validation.  Data Validation using Clintrial Manage, Resolve modules.  Resolving all the queries generated.  Updating database in accordance with response to queries through DCFs (Data Clarification Forms).  Data review and generating listing and reports using I-Review and SAS.  Acquisition and management of external data like Lab Data.  Independently Handling Projects.  Co-ordination of Data Management Projects with departments.  Data review and generating listing and reports using I-Review and SAS.