Mani Kanta

Experience

• 

  Lotus Labs Pvt Ltd

  Feb 2008 - Oct 2012

  Left Lotus Labs , joined Quintiles Technologies Promoted to Senior Clinical Research Coordinator

  • Senior clinical research coordinator

    Apr 2011 - Oct 2012

  • Clincal research coordinator

    Feb 2008 - Apr 2011
• 

  IQVIA

  Oct 2012 - May 2020

  • Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages• Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified. Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial• Ensures proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial• Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient• Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)• Review any other information as necessary to determine overall readiness of the patient information for next level review• Review all supplied Line Listings to determine data accuracy across patients within a specified group of data points• Review status information and data flow reports and take appropriate actions• Serve as POC/ Back-up POC• Interaction with other Medical review staff to verify/clarify information and/or triage new data issues or prior identified action items• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. Show less

  • Senior Centralized Monitoring Lead

    May 2018 - May 2020

  • Assistant Medical Data Review Manager

    Apr 2014 - May 2020

  • Senior Medical Data Reviewer

    Oct 2012 - Apr 2014
• 

  PPD

  May 2020 - now

  Risk Based Monitoring - Data Analytics

  • Follows established guidelines for the review of clinical trial data using a variety of tools and systems • Review the RIs such as data entry currency, Query management, Subject enrollment, deviations, Adverse events, potential fraud, medical history, treatment compliance and their sub RIs.• In alignment with the centralized monitoring plan independently with little/no support • Analyze the data and update the findings and observation in the jira reporting format. • Characterizes and tracks the evidence of issues, signals and potential risks with inputs as needed from DA Lead/Manager. • Responsible for ensuring results of reviews are appropriately documented per department procedures. • Supports DA teams with performance of assigned reviews with high quality, on-time results with more • complex analyses or deeper root cause analyses and begins to connect related signal to risks • Provides input to Lead and/or Manager as needed to support development of risk characterization and reporting. • Supports review set-up as directed by assigned study lead/manager including updating department Show less