Yogesh Patil

Experience

• 

  Tata Consultancy Services

  Oct 2015 - Jul 2017

  Clinical Data Manager

  • Therapeutic Area: Neuroscience, Immunology and Medical Device study• Maintains full understanding of protocol including study documentation.• Preparation of quality control plan as per the SOPs.• Writing eCRF specifications.• Preparation of protocol deviation document.• Drafting eCRF completion guidelines.• Preparing data transfer agreement for vendor.• Writing DVR specification and writing test steps.• Creation of UAT plan, performing UAT and preparing UAT report.• Preparing and maintain DMP metrics.• Performing discrepancy management in accordance with the agreed timelines.• Reviewing all protocol deviations.• Escalate any discrepancy in the clinical data to the LDM/DA, TA Lead as appropriate.• Identifying issues with validation procedures during study conduct and communicate finding to LDM/DA, TA Lead.• Point of contact to monitor for data flow, discrepancy management, and all other data management related process.• Communicating site data issues (dataflow, discrepancies, etc) with LDM/DA, TA Lead, sites, and monitors.• Performing SAE reconciliation.• Performing vendor data reconciliation• Executing data listing programs and dataset reviews for patient data consistency, quality and completeness.• Perform discrepancy management on front end checks and the programmed consistency checks (backend checks).• Utilization of appropriate data management tools to monitor quality and timeliness of dataflow for assigned sites.• To ensure error free, quality data with no open queries prior to database lock.• Co-ordinates with the LDM/DA, TA Lead with respect to any unresolved queries and close the same.• Efficacy analysis and database closures.• Performing data base lock and freezing.• Co-ordinate with coding team for coding related activities.• Supporting CDM in developing study metrics and study status reporting Show less

• 

  Cognizant

  Jul 2017 - Jun 2018

  Clinical Data Manager

  • Therapeutic area: Immunology• Maintains full understanding of protocol including study documentation.• Drafting eCRF completion guidelines.• Performing discrepancy management in accordance with the agreed timelines.• Escalate any discrepancy in the clinical data to the LDM/DA, TA Lead as appropriate.• Identifying issues with validation procedures during study conduct and communicate finding to LDM/DA, TA Lead.• Point of contact to monitor for data flow, discrepancy management, and all other data management related process.• Communicating site data issues (dataflow, discrepancies, etc) with LDM/DA, TA Lead, sites, and monitors.• Performing SAE reconciliation.• Performing vendor data reconciliation• IVRS reconciliation.• E-dairy reconciliation.• Lab data reconciliation.• ECG reconciliation• Executing data listing programs and dataset reviews for patient data consistency, quality and completeness.• Perform discrepancy management on front end checks and the programmed consistency checks (backend checks).• Utilization of appropriate data management tools to monitor quality and timeliness of dataflow for assigned sites.• To ensure error free, quality data with no open queries prior to database lock.• Co-ordinates with the LDM/DA, TA Lead with respect to any unresolved queries and close the same.• Co-ordinate with coding team for coding related activities. Show less

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  IQVIA Asia Pacific

  Jun 2018 - Sept 2020

  Clinical Data Specialist

  • Therapeutic Area: Oncology• Maintains full understanding of protocol including study documentation.• Performing discrepancy management in accordance with the agreed timelines.• Escalate any discrepancy in the clinical data to the LDM/DA, TA Lead as appropriate.• Identifying issues with validation procedures during study conduct and communicate finding to LDM/DTL, TA Lead.• Point of contact to monitor for data flow, discrepancy management, and all other data management related process.• Communicating site data issues (dataflow, discrepancies, etc) with LDM/DA, TA Lead, sites, and monitors.• Performing SAE reconciliation.• Performing vendor data reconciliation (IWRS, Histogenex, Imaging)• Perform protocol deviation review and report the PD in PDIE module• Perform local lab outlier’s data review• Executing data listing programs and dataset reviews for patient data consistency, quality and completeness.• Perform discrepancy management on front end checks and the programmed consistency checks (backend checks).• Utilization of appropriate data management tools to monitor quality and timeliness of dataflow for assigned sites.• To ensure error free, quality data with no open queries prior to database lock.• Co-ordinates with the LDM/DTL, TA Lead with respect to any unresolved queries and close the same.• Co-ordinate with coding team for coding related activities Show less

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  Accenture

  Oct 2020 - now

  • Sr. CDM Scientist/Deputy General Manager

    Jun 2022 - now

  • Clinical Data Scientist

    Oct 2020 - Jun 2022