Experience

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  Hindawi publishing

  Mar 2014 - Oct 2014

  Copyeditor
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  Children cancer hospital 57357

  Oct 2014 - Jul 2016

  Clinical research associate and clinical data management specialist

  Responsibilities were follows:• Monitoring physicians’ adherence to standard treatment protocol and reporting violations of the protocol to quality department;• Performing and coordinating clinical studies and protocol development;• Preparing semi-annual reports about the survival status of the patients;• Maintaining contact with study investigators to make sure studies are going well and as planned;• Reviewing cases with investigators to determine discrepancies;• Data collection, management, and analysis using REDCap (Research Electronic Data Capture Application) and SPSS statistics software;• Providing training lectures to nurses;• Designing Electronic Case Report Forms (CRFs) for clinical trials;• Providing continuous staff training on basics of data management, software used, and any other technical procedures.• Providing adequate training to clinical data management specialists.• Developing Standard Operating Procedures (SOPs) that regulate the utilization of the clinical database used and those include the following:• Initiation of new project• Modification of existing project• Data release and transfer• Adding new users• Developing Data Management Plan (DMP) for standard treatment protocols and different projects at CCHE, maintaining DMP throughout lifecycle of study project, and ensuring that DMP is followed according to study design and requirements.• Developing databases (DB) for standard treatment protocols, through designing eCRF and managing user rights, edit rules/checks, and data validation, that comply with the DMP and statistical analysis plan (SAP).• Coordinating the archiving of obsolete databases and related documents. Show less

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  Novartis

  Jul 2016 - May 2019

  - Organizing, coordinating, and ensuring the execution of LSS (Staff and operators) training activities as per annual training plan.- Follow up on cGMP, HSE and Novartis regulatory compliance activities within the PU (Process Unit). -Preparation for upcoming audits whether internal or external audits.- Performing regular GMP walkthroughs according to a pre-set plan.- Ensuring that all operational activities are compliant with cGMP, HSE, andNovartis standards. -Ensure good documentation practices (GDP) are implemented. -Coaching personnel within the LSS process unit. -Troubleshooting during daily operation and process improvement. -Reviewing manufacturing documents (e.g. filled batch record, deviation reports,logbooks etc...) within LSS process unit to ensure continuous operational running.- Ensuring smooth implementation of manufacturing plan. Show less Responsibilities were as follows:-Member of PQR team where I have been responsible for issuance of Annual Product Quality Review Reports .-Member of Global Operating Procedures (GOPs) and Quality Modules Implementation team - Member of Supplier Qualification team -Conducting Self Inspection in order to assure compliance with the Novartis Quality Manual and encompassing current regulatory requirements, expectations, and industry trends.-Follow-up on Execution of Global Compliance Audits' CAPA plan with zero overdue actions.- Member of the back office during assessments. Show less

  • GMP and training coordinator/ Liquid and semisolid process specialist

    Jan 2018 - May 2019

  • Central Compliance Officer

    Jul 2016 - Dec 2017
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  The janssen pharmaceutical companies of johnson & johnson

  May 2019 - now

  • Senior Commercial Quality Executive-GCC and JENA

    May 2022 - now

  • Commercial Quality Executive (JENA and GCC)

    May 2019 - May 2022