
Nada Mounir
Summer Trainee

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About me
Regulatory Affairs Executive Africa Cluster - FWCA GSK
Education

Collège du Sacré Cœur - Ghamra
2003 - 2013High School Diploma Biology, General Excellent (98.6%)Activities and Societies: MEJ, Class President

St. Jeanne Antide - Alexandrie
1999 - 2003School
Ain Shams University
2013 - 2018Bachelor of Pharmacy - BPharm Pharmacy Very GoodActivities and Societies: SCOPS, Clinical Pharmacy Workshop
Experience

Parkville Pharmaceuticals Egypt
Jul 2015 - Aug 2015Summer TraineeSales Training

Sanofi
Aug 2015 - Sept 2015Summer InternClinical Research Departement

SCOPS -Students' Conference On Pharmaceutical Studies-
Jan 2016 - Apr 2016ParticipantClinical Pharmacy Workshop( Visited El Abasseya & 57357 Hospitals)

Sami Refaat Pharmacy
Jul 2016 - Jan 2020Community Pharmacist
Servier
Aug 2016 - Sept 2016Sales Quality Control & Production Departments
Summer Trainee
Sept 2016 - Sept 2016Summer Trainee
Aug 2016 - Aug 2016

LEO Pharma Inc. US
Jul 2017 - Sept 2017Summer InternSales

Children's Cancer Hospital - Egypt 57357
Sept 2018 - Jan 2021Clinical 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 2024Clinical Research Associate
Jan 2023 - May 2023Clinical Trial Administrator
Jan 2021 - May 2023

GSK
Apr 2024 - nowRegulatory Affairs Executive
Licenses & Certifications

NIH Course on Protecting Human Research Participants
NIHSept 2018
DELF B2
Centre Culturel FrancaisNov 2010
Good Clinical Practice
NIDA Clinical Trials NetworkOct 2018
Languages
- frFrench
- enEnglish
- arArabic
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