Nada Mounir

Nada Mounir

Summer Trainee

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location of Nada MounirCairo, Egypt

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  • Timeline

  • About me

    Regulatory Affairs Executive Africa Cluster - FWCA GSK

  • Education

    • Collège du Sacré Cœur - Ghamra

      2003 - 2013
      High School Diploma Biology, General Excellent (98.6%)

      Activities and Societies: MEJ, Class President

    • St. Jeanne Antide - Alexandrie

      1999 - 2003
      School
    • Ain Shams University

      2013 - 2018
      Bachelor of Pharmacy - BPharm Pharmacy Very Good

      Activities and Societies: SCOPS, Clinical Pharmacy Workshop

  • Experience

    • Parkville Pharmaceuticals Egypt

      Jul 2015 - Aug 2015
      Summer Trainee

      Sales Training

    • Sanofi

      Aug 2015 - Sept 2015
      Summer Intern

      Clinical Research Departement

    • SCOPS -Students' Conference On Pharmaceutical Studies-

      Jan 2016 - Apr 2016
      Participant

      Clinical Pharmacy Workshop( Visited El Abasseya & 57357 Hospitals)

    • Sami Refaat Pharmacy

      Jul 2016 - Jan 2020
      Community Pharmacist
    • Servier

      Aug 2016 - Sept 2016

      Sales Quality Control & Production Departments

      • Summer Trainee

        Sept 2016 - Sept 2016
      • Summer Trainee

        Aug 2016 - Aug 2016
    • LEO Pharma Inc. US

      Jul 2017 - Sept 2017
      Summer Intern

      Sales

    • Children's Cancer Hospital - Egypt 57357

      Sept 2018 - Jan 2021
      Clinical Research Specialist

      • Protocol Monitoring and Patient follow up according to SOPs and Protocol milestones.• Work with senior CRS to develop protocol milestones.• Participate in presentations, reports and any required data concerning assigned disease.• Participate in reporting the KPIs related to the protocols.• Coordinate with the study team in the Development of standard treatment protocols and protocol amendments, roadmaps, preprinted orders, required information for CRF and facilitate the related approvals.• Facilitate, coordinate and participate in the disease related research studies and papers.• Biannual Statistical Data analysis according to SOPs. Show less

    • Novartis Egypt

      Jan 2021 - Apr 2024

      • Main Responsible of Local Drug Depot for Novartis Premises at Cairo, Egypt, as per SOPs and ensuring compliance with GMP/GDP, including:1. IMP Accountability at Local depot and investigational sites.2. Handling/Reporting of temperature excursions.3. Managing the global and Local shipments and shipments.4. Using Cenduit system.5. Handling of IMP destruction process after study close-out.• Tracking & filing essential documents in the relevant document management systems when they are retrieved from sites, as well as maintaining eTMF up to date (Egypt & Levant/Gulf Countries).• Preparing & Tracking Clinical Trial Submission Packages to different Ethics Committees & Health Authorities (MoH/EDA).• Archiving study documents (mDoc or Local Vendor)• ACT Maintenance & Local Studies expenditures reconciliation.• Co-monitoring (Supporting in IF & IMP Accountability) Show less

      • Regulatory Affairs Associate

        Jun 2023 - Apr 2024
      • Clinical Research Associate

        Jan 2023 - May 2023
      • Clinical Trial Administrator

        Jan 2021 - May 2023
    • GSK

      Apr 2024 - now
      Regulatory Affairs Executive
  • Licenses & Certifications

    • NIH Course on Protecting Human Research Participants

      NIH
      Sept 2018
    • DELF B2

      Centre Culturel Francais
      Nov 2010
    • Good Clinical Practice

      NIDA Clinical Trials Network
      Oct 2018