Azra Qizilbash

About Azra Qizilbash

Experienced Clinical Trial Manager with a demonstrated history of working in the…

Experience

1. Country Clinical Study Manager

   Novartis

   Nov 2018 — Present

   USA Country Lead\\\\n• Phase Neuroscience, Multiple Sclerosis, Global Studies.\\\\n• Responsible for contingency plans to ensure recruitment targets are achieved in accordance with global trial execution plan.\\\\n• Ensures recruitment targets are met and reviews enrollment at the site level including responsibility for approval of enrolling above site targets.\\\\n• Ensuring that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders.\\\\n• Oversee local clinical team activities to achieve study timelines and quality execution, proposing and implementing corrective actions where appropriate, according to Novartis standards and local and international regulations.\\\\n• Tracks study status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans, to ensure all study operational aspects are on schedule.\\\\n• Forecast local Investigational Medical Product (IMP) and comparator needs as appropriate. Ensures IMP is available to commence and complete assigned trial/assigned trial sites.\\\\n• Oversee third party CRO vendor performance.\\\\n• Maintains oversight of country level data management activities.\\\\n• Proficient working knowledge of Good Clinical Practice (GCP).\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n