Pooja Thakkar

Experience

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  Infosys BPO

  May 2006 - Aug 2008

  Process exectuive
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  Cognizant Technology Solutions

  Oct 2008 - Mar 2011

  Data Manager

  • Worked as a SPOC (handling team) for various activities like Offline listings, Vendor reconciliations, SAE reconciliation, DCF listings.• Review and understand the study protocol and the timelines.• Create eCRF completion guidelines for sites. • Conduct sponsor User Acceptance Testing (UAT) of EDC systems to ensure screening design matches protocol & edits are programmed & operating as intended & escalate the errors identified to the CDM study manager. • Attend relevant study teleconference with the Sponsor staff to communicate and address any study related issues or concerns. • Responsible for various other activities including testing of Validation Procedure, Database testing and handling discrepancies in Database as per protocol. • Perform external checks to handle manual discrepancies and action the same. • To freeze and lock data as appropriate in time for statistical review blinded interim quality review, interim and final database lock. • Coordinate with the CDM study manager to understand the specific requirements of the study & receive the relevant tabs of study file from the CDM study manager. • Understand Dataset specifications, Subject Visit Walk Through and Vendor data requirements. • Completion of Final data reconciliation i.e., PGx, PK, LAB. • Validation of external vendor data & address the post DBR and DBF queries, liaising with the sites and monitoring to ensure all eCRF’s signed.• Review and understand study protocol and the study timelines• Escalate any discrepancy in the clinical data to the DM study manager as appropriate • Action study team feedback as required on the data.• Perform external checks to handle manual discrepancies and action the same• Review the resolved discrepancies and close where appropriate• Providing query metrics as per request of query manager• To ensure an error free, accurate and quality data • Attend study teleconference with the client staff Show less

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  Syneos Health

  Mar 2011 - Oct 2021

  Senior Clinical Data Manager

  • Attending Meeting with Client/Vendors OR trainings on the study trial to better understand the fine aspects of the trial.• Creation and updating of documentation supportive of clinical trial data handling.• Perform external checks to handle Manual Discrepancies and action the same.• Provide weekly and monthly status report of the trial to the client. • Coordinate with Study manager & with external stakeholders with respect to any unresolved Queries and close the same to ensure an error free, quality data • Notifying any discrepancy in the clinical data to the Study manager as appropriate & action study team feedback as required on the data.• Perform Quality Check of: Queries & Edit Checks. • Identifying and analysing Quality related errors and suggesting preventive/ corrective actions based on the causal analysis of errors.• Conducting Meeting with Client, Project Manager, Team/Group Leaders & study team members to discuss Quality Control observation/error.• To ensure all the data discrepancies are addressed & resolved before Database Lock.• Defines the study specific non-CRF data handling strategy to ensure requirements are met appropriately• Proactively checks all inbound non-CRF electronic data for any potentially unblinding data as defined in the protocol and ensures study integrity by sequestering unblinding data until data release is authorized.• Reviewed and refined the technical requirements with service provider to establish the transfer of non-CRF data.• Establish appropriate transfer methodology with external data provider to ensure validity.• Perform verification and resolve data transmission, file format and loading errors with data providers.• Lead or participate in the local functional/cross-functional implementation of best practices and process improvement initiatives• Effectively communicate ideas, project goals and status of work and independently present at department meeting. Show less

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  IQVIA Asia Pacific

  Oct 2021 - now

  Data Team Lead

  • Initiating Meeting with Client for understanding• Lead the Team to ensure quality, timelines.• Responsible for TMF Management plan and quality and completeness of assigned projects.• Accountable for all project deliverable for each project assigned.• Coordinate activities and deliverables of all project partners and proactively identify and manage issues.• Accountable for maintenance of project information on a variety of databases and systems.• Plan, coordinate and present at internal and external meetings.• Direct the activities of assigned project support staff.• Prepare project management reports for client and management.• Implement resource strategies to achieve project goals.• Developing contingency planning and risk mitigation strategies to ensure successful delivery of program goals.• Responsible for performing activities that are in compliance with applicable corporate and divisional policies, SOP’s & operative guidelines and performing other duties as assigned by management.• Set priorities and schedule activities accordingly and create alternative solutions to address business and operational challenges. Show less