Pritam N.

Data Management Consultant at Accenture
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Contact Information
us****@****om
(386) 825-5501
Location
Bengaluru, Karnataka, India, IN
Languages
  • English Full professional proficiency
  • Hindi Full professional proficiency
  • Marathi Native or bilingual proficiency

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Credentials

  • Base SAS
    Private institute

Experience

  • Accenture
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Data Management Consultant
      • Nov 2018 - Present

      Individual Contributor Individual Contributor

  • Syneos Health Clinical Solutions
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Data Manager II
      • Jun 2015 - Nov 2018

      - Design and Devlop CRFs and participate in the review of sponsor-generated CRFs - Creation of DMP for study/project- Act as the Lead Clinical Data Manager for assigned studies or projects- Define edit checks to be programmed for the study/project- Review and Validate programmed edit checks (UAT)- Process electronic data received from Third party vendors - Perform data review and query generation- Track study progress and issue periodic status reports- Participate in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor

  • Tata Consultancy Services
    • India
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Senior Process Associate
      • Dec 2013 - Jun 2015

      Responsible for attaining all requirements from the client for quality deliverable- Creation of DVR specifications and Test scripts - Creation of UAT plan, performing UAT - Review and creation of Protocol deviation document- Discrepancy management and external vendor data reconciliation- Prepration of Data Transfer Agreement for Extenral data- Identifying issues with validation procedures during study conduct and communicates findings to TA Lead and Client- Monitoring and supporting SAE reconciliation- Utilization of appropriate data management tools to monitor quality and timeliness of data flow for assigned sites- To ensure error free, quality data with no open queries before database lock- Performing and monitoring Data base lock and freezing activity- Efficacy analysis and database closures.

  • Cognizant
    • United States
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Clinical Data Analyst
      • Dec 2011 - Dec 2013

       Perform assigned data management activities with focus on quality and timelines. Review and action Discrepancies on an ongoing basis and Discrepancy management. Creation of Edit checks Specification and test cases. Co-ordination of User Acceptance Testing (UAT) according to Validation Plan of all applicable Data Management systems. Creating the Data transfer specifications for Non-CRF data. Executing Data Loading of Non-CRF data. Identifying and managing any issues with the Non-CRF data received or issues while data Loading Extract data listings and perform manual data review Provide listings for review to study team as per the timelines defined in the data handling plan and action discrepancies as per review comments.  Perform ongoing and final consistency checks, review protocol deviation handling document and data listings to ensure that all data have been cleaned appropriately according to the Data handling plan Training new joiners and perform QC of Discrepancies. Support Quality control checks for the trial Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements

  • inVentiv Health Clinical
    • United States
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Clinical Data Processor
      • Sep 2010 - Dec 2011

       Discrepancy management and reconciliation activities. Review Discrepancies and update database according to Discrepancy resolution. Performing QC of Clinical Data. Extract Data listings and perform Manual review of Discrepancies. Perform Second pass entry of Clinical data. Handling Problem Queue as per requirement, review missing page reports. Performing Self Evident Corrections as per instructions from Data managers. Maintaining detailed daily records of all ongoing projects. Training new joiners’ and supervision of all Data Processing activities to ensure that all goals and objectives are met.

Education

  • Manipal Academy of Higher Education
    Master's degree, Clinical Research & Regulatory affairs
    2008 - 2010
  • University of Pune
    Bachelor of Pharmacy (B.Pharm.), Pharmacy
    2004 - 2008

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