Experience

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  Accenture services

  Mar 2007 - Jun 2011

  Sme, clinical data management

  • Conduct training sessions for new hires in Oracle Clinical (database, RDC-TAO Classic/Onsite). • Prepare training materials for data management activities and processes as required.• Manage the smooth conduct of studies assigned by ensuring trained resources were working on the studies and in sufficient numbers to manage the workload.• Participate in the development and maintenance of study-specific guidelines.• Conduct study discussion conferences with clients, participate in IPT (Integrated Project Team) meetings, and discuss data quality issues with Client. • Review the Issue Escalation Trackers completed by the Data Managers for Oncology studies, and provide resolutions, keeping the sponsor Protocol Data Manager informed of the resolutions provided.• Develop strategies in co-ordination with Operations Lead so as to meet quality requirements efficiently and meet timelines/SLA’s set by the client.• Identify trends in types of errors made by Data Managers and suggest/implement course of action.• Perform regular quality check on data processed by individual Data Managers and record their quality scores.• Drive improvements in data reviewing process to ensure excellent editing quality for assigned studies.• Forecast capacity towards forecasted work force. Monitor timelines to ensure data management-related deliverables are met.• Track projects and metrics- Ensuring that the Data Managers complete the review and cleaning of patients within the given timeline and ensure all client SLAs are met.• Take interviews for vacant positions for Clinical Data Manager.• Coordinating with the trainers and mentors to ensure that the new hires are trained efficiently and timely so that they can successfully complete the certification test and work on production database. • Perform key data set reconciliations- (SAE, LAB data) and perform regular Data Management maintenance activities. • Provide editing support as and when feasible. Show less

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  Novartis oncology

  Jun 2011 - Jan 2015

  Clinical data manager

  • Provide professional DM input on Clinical Trial Team(s)• Input to and review of clinical trial database design including User Acceptance Testing (UAT).• Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.• Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks.• Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.• Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.• Support and provide leadership for data management staff for allocated trials. • Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock. Show less

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  Novartis

  Feb 2015 - now

  • GCP Compliance Manager

    Aug 2023 - now

  • Senior Principal Clinical Data Manager

    Apr 2020 - Jul 2023

  • Principal Clinical Data Manager

    Apr 2018 - Mar 2020

  • Senior Data Manager

    Feb 2015 - Mar 2018