Himani Bhardwaj

About Himani Bhardwaj

As a Sr. Patient Recruitment Specialist at IQVIA, I collaborate with internal delivery…

Experience

1. Senior Project Analyst (Risk Based Quality Management)

   ICON plc

   Apr 2024 — Present

   Responsible for supporting the activities of RBQM (Risk-Based Quality Management) within theICON Biotech division, across a wide variety of therapeutic areas, clients and projects.Ensure robust and high-quality initial study risk assessment and, ongoing risk managementoccurs on every study, in accordance with required timelines and with SOPs and ICH-GCPguidelines.Oversee risk management tool completion and updates throughout study, e.g. to ensure criticaldata and process identification, risk initial input occurs, and overall quality is achieved with riskand mitigation identification.Ensures risk-based monitoring strategies are included in all applicable functional plans, andensures strategies are correctly configured in technology solutions.Supports RBQM Kick off and Quality Gates assessments during study start up, and during studychange implementation by kick starting the process with Protocol Risk Evaluation.Production of risk management metrics (e.g, compliance, mitigation effectiveness, deviationmanagement).Analyze, summarize & report on Risk Management; trend analysis to inform future knowledgelibrary.Ensure Continuous risk and issue management process is carried out by establishing a riskmgmt. framework, regular risk assessment and review, documenting risk and issues, monitoringand communicating risks to wider team and sponsor, following escalation procedure,implementing mitigation plan and contingency actions and Documenting lessons learned fromrisk and issue management for future studies, allowing the team to improve processes.Ensure agreement on Quality Tolerance Limits (parameters and thresholds) achieved with studyteams by identifying relevant parameters that directly impact the quality of the study, review andapproval of QTLs, establishing strategy for continuous monitoring and reporting as per ICH GCP.

Education

• RBSE

  XII

• Gautam Budh Technical University

  Bachelor of Technology (BTech)

  2009 — 2013

• Gautam budh technical university

  B.Tech

  2009 — 2013

• Clini India

  Diploma in Clinical research

  2015 — 2015

Skills

• Fermentation Technology
• Microsoft Office
• Clinical Research Experience
• Food Technology
• Molecular Biology
• Biotechnology
• Powerpoint
• Microbiology
• Alcohol Technology