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Naz E Farha Hakeem

Naz E Farha Hakeem

Medical Data Reviewer
Bengaluru, Bengaluru Urban

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About Naz E Farha Hakeem:

  • Effective communication skills, with demonstrated ability to talk and listen to people and build rapport with them.
  • Computer proficiency and familiarity with database management programmes and commonly used packages like MS Word, Excel, PowerPoint, Oracle Clinical, Rave, Spotire.
  • Strong understanding of regulatory procedures and guidelines like , ICH-GCP, GATS survey, SOP etc.
  • Statistical proficiency with various softwares and techniques include SPSS, Predictive analysis, Regression analysis and query language.

Experience

Current role – FSP – Medical Data Analyst - Data management Team in IQVIA since FEB 2020 – Present

  • As a Process POC, built a team of 4, working on a Cardiovascular Study- hyperlidemic drug.
  • Serve as SME- for Data management plan(DMP) and Spotire built and visualization.
  • As a functional service Provider. I provide medical review of data listings for Adverse Events, concomitant medications, medical history, eligibility criteria, protocol deviations, labs, vitals, ECGs and RECIST criteria, other study specific data, and patient profiles; preparation of periodic summary reports for safety data, Safety Trend Analysis Report (STAR)F
  • Provide outlier analysis and generate queries for missing/discrepant data through database lock    
  • Perform coding review of Serious Adverse Events, medical history, concomitant medication and AE line listings for accuracy and consistency  
  • Proficiency in the use of data listings, patient profiles, data analytic platforms, e.g.: Qlik Sense, and various EDCs systems including Medidata RAVE and INFORM
  • Prepare periodic MDR summary reports
  • Identify anomalies in patient reported data by performing Subject Level Data Review, querying clinical sites to determine accuracy as required
  • Provide aggregate review of safety information including medical data, to maintain oversight of the Investigational product’s safety profile. 
  • Compose Safety Trend Analysis Report to summarize medical data reviewed and highlight critical findings
  • Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines, J-Review Reports.
  • Performs QC of DMSF after Quick Start and ongoing during the study conduct.
  • Provides EDC training to internal and external team members via Teleconference.
  • Conduct in-stream data trend analysis in support of data quality and integrity including protocol compliance and targeted review of patient data
  • Ensure data quality focus to audit readiness with regulatory compliance
  • Provide medical review of coded listings, such as adverse events, medical history, concomitant medications or other medical data listings to verify medical accuracy of clinical data
  • Define data capture requirements in line with protocol and reporting needs
  • Support data analytics by reviewing the visualizations and identify and escalate potential issues of concerns
  • Present data at multi-disciplinary internal and/or client meetings as required
  • Maintain strong customer relationships
  • With guidance, track performance and identify issues requiring remediation and their root causes, and implement remedial actions as required
  • Ensure timely follow-up and resolution of compliance issues
  • Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
  • Attend Kick-Off Meetings, weekly team meetings, and client meetings, as required or requested
  • Participate in activities involving risk assessment and measuring the effectiveness of risk minimization measures
  • Drive the delivery of end-to-end study data quality and integrity
  • Perform special projects as requested by management

Education

  1. MDS - Public Health- KLE Dental college
  2. BDS - Bapuji Dental College

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