Twinkle Juneja

Experience

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  DSG, Inc.

  Apr 2014 - May 2016

  Clinical Data Reviewer, Clinical Data Management

  Job Description: Support CDM in study start up activities, including user acceptance testing. Review clinical trial data as per SOP, protocol, and study specific guidelines. Discrepancy Management : Issue and review queries for missing, inconsistent, illegible, or erroneous data; follow queries to resolution  Ensure quality in all data cleaning efforts, including: External Data cleaning, such as lab data review and Serious Adverse Event reconciliation. Create ad-hoc listings to review ongoing clinical study data. Assist with maintenance of all relevant clinical trial documentation. Communicate data issues and/or query trends to CDM  Interact with various Data Management and other functional area colleagues such as Project Management and Project Coordination, and Site personnel. Show less

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  Cognizant Technology Solutions Pvt Ltd

  Jun 2016 - Jan 2017

  Senior Process Associate

  Clinical Data Management activities.

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  Novartis

  Jan 2017 - Jun 2022

  1. Reviews and contributes to preparation of protocols, specifically related to the Visit Evaluation Schedule (VES), Study Design and Data Management section.2. Gives input to Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials. Responsible for the development of these documents if works as a TDM.3. Performs DM activities for start-up of a study including preparing the eCRF, CCGs, DHPs, DRPs and performing User Acceptance Testing (UAT).4. Performs ongoing review of all data generated from the clinical study including central and local lab data and coding.5. Performs review of listings for quality, content, format and output.6. Identifies possible trends in data Leads and participates in the final review of all data generated from the clinical study. Show less

  • Program Clinical Data Manager

    Sept 2021 - Jun 2022

  • Senior Clinical Data Manager

    Apr 2019 - Aug 2021

  • Clinical Data Manager

    Jan 2017 - Mar 2019
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  AstraZeneca India

  Jun 2022 - now

  • Associate Director, Data Management, Study Data Manager

    Oct 2024 - now

  • Global Data Management Lead, Senior Clinical Data Manager II

    Jun 2022 - Sept 2024