Project Manager

• Nov 2020 - Present

Real World Evidence Sr. Consultant | Project Manager

• Nov 2018 - Nov 2020

Sr. Clinical Research Associate

• Sep 2016 - Aug 2018

• Maintains knowledge & ensures compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs, project-specific procedures & project scope, budget, (e.g., Project & Monitoring Plan).• Ensures timely completion of role-based and project-specific training.• Supports appropriate selection of qualified investigational sites (with clinical project manager/project team).• Builds strong and lasting relationships with site investigators and site teams/staff.• Schedules, plans, prepares for and then performs site monitoring visits according to the monitoring plan and SOPs to ensure appropriate monitoring activities are completed at each onsite or remote visit (e.g., SDV, site staff training, investigator site file review, compliance checks, drug accountability, observational visits, facility review, etc.).• Submits to and follows up with site staff on Clinical Site Agreements (CSA) (including budget), and site-specific Informed Consent Forms (ICF).• Provides prepared EC package to the Principal Investigator (PI) for submission and follows up to secure approval where required.• Plans and evaluates patient recruitment, reviews and provides updates to applicable project tracking systems.• Reviews subject safety data and AEs/SAEs and ensures appropriate follow-up and escalation according to protocol/regulatory requirements.• Responds to site issues ascertains and recommends appropriate follow-up response to problems including potential deficiencies in documentation, communication, and the need for additional training.• Evaluates overall compliance and performance of sites and site staff: provides recommendations regarding site-specific actions and uses judgment and experience to assess the ability and motivation of site staff.• May assist project manager or clinical team manager on assigned projects and/or may help in the mentoring and training of junior clinical team members.

Clinical Data Manager

• Sep 2016 - Aug 2018

• Provides clinical data management support to Clinical Operations team and/or Study Project, Clinical Data Management team, and Biostatistics team.• Develops Data Management Plan (DMP), maintains DMP throughout the lifecycle of study project and ensures DMP is followed according to study design and requirements.• Participates in the review of clinical research documents (e.g., Protocols, Case Report Forms [CRFs] and Statistical Analysis Plans [SAPs]).• Develops paper and/or electronic CRFs (eCRF) packages with the Medical Writing and Clinical Operations teams: CRF design guide, layout, general instructions, standardization, the procedure for transfer, corrections and amendments, CRF transmission log, CRF printing, distribution, and tracking.• Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.• Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.• Decides where and how data captured from Patient Reported Outcomes (PROs) via the Web, an e-diary device, or other data device, will be integrated with CRF data captured through the EDC system.• Performs training on study trial for EDC and create user guides.• Assists in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.• Assists in reconciling and coding AE/SAE data in Safety DB and/or other data.• Assists and provides input into the study and project-level data analysis plan.• Participates in the preparation and presentation of data, when applicable.• Ensures data system compliance by following the established guidelines of national and international regulatory authorities.• Participates in conference calls and/or meetings with vendors.

Feasibility Manager

• Jul 2017 - Sep 2017

Feasibility Manager Assignment

Clinical Research Associate

• May 2015 - Sep 2016

1. Complete appropriate therapeutic, protocol and clinical research training to perform job duties.2. Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Research Specialist (CRS) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as Data Management and Pharmacovigilance.3. Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.4. Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.5. Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), CRS and/or line manager.6. Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.7. Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

Integrated site service Coordinator, MENA

• Feb 2013 - May 2015

1. Assist project team members with preparation, distribution and tracking of ethics and regulatory submissions according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.2. Assist in maintenance of Site Start-Up (SSU) tracking entries in database and/or tracking spreadsheets.3. Assist in resolution of site issues and report status to SSU Team Lead.4. Maintain working files per project instructions. Perform archiving activities under the direction of the SSU Team Lead.5. Prepare and distribute internal documentation and reports.6. Assist project team members in the identification of study sites.Therapeutic ExperienceTherapeutic Area: Hematology / Oncology / TransplantationYears Experience: 2Indication: Malignant Melanoma Therapeutic Area: Hematology / Oncology / TransplantationYears Experience: 2Indication: Head and Neck Cancer Therapeutic Area: EndocrinologyYears Experience: 1.5Indication: Gaucher's Disease Therapeutic Area: Hematology / Oncology / TransplantationYears Experience: 1Indication: Sickle cell DiseaseYears Experience: 0.5 Therapeutic Area: NeurologyYears Experience: 0.5Indication: Multiple Sclerosis Therapeutic Area: NeurologyYears Experience: 0.5Indication: Spinal Cord Disease Therapeutic Area: Hematology / Oncology / TransplantationYears Experience: 0.5Indication: Other Therapeutic Area: Hematology / Oncology / TransplantationYears Experience: 0.5Indication: Non-Small Cell Lung Cancer

Regulatory & Site Start-Up Assistant, MENA

• Jun 2012 - Feb 2013

1. Assist project team members with preparation, distribution and tracking of ethics and regulatory submissions according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.2. Assist in maintenance of Site Start-Up (SSU) tracking entries in database and/or tracking spreadsheets.3. Assist in resolution of site issues and report status to SSU Team Lead.4. Maintain working files per project instructions. Perform archiving activities under the direction of the SSU Team Lead.5. Prepare and distribute internal documentation and reports.6. Assist project team members in the identification of study sites.Therapeutic Area: EndocrinologyYears Experience: 0.5Indication: Diabetes Mellitus Type 2 Therapeutic Area: PsychiatryYears Experience: 0.5Indication: Schizophrenia

Site Start-Up Coordinator Intern

• Apr 2012 - Jun 2012

1. Assist project team members with preparation, distribution and tracking of ethics and regulatory submissions according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.2. Assist in maintenance of Site Start-Up (SSU) tracking entries in database and/or tracking spreadsheets.3. Assist in resolution of site issues and report status to SSU Team Lead.4. Maintain working files per project instructions. Perform archiving activities under the direction of the SSU Team Lead.5. Prepare and distribute internal documentation and reports.6. Assist project team members in the identification of study sites.

Staff Pharmacist

• Oct 2010 - May 2012

1. Dispenses medications following prescriptions issued by an authorized medical practitioner.2. Reviews prescriptions for appropriateness of therapy to determine ingredients needed and to ensure correct dosage.3. Inventories, orders, and maintains supply of drugs, chemicals, and other pharmaceutical stock.4. Advises patients and care providers of potential drug interactions, possible side effects, storage information, and instructions on how to use medications.5. Presents drug lectures to medical nursing staff, physicians, and other groups on matters pertaining to pharmacy.6. Prepares sterile products for patient administration; determines proper preparation, packaging, sterilization, storage, and stability requirements of the product.7. Trains and supervises Pharmacy Assistants as assigned.8. Serves as a preceptor for pharmacy interns.

Novartis Bio-camp Egypt 2010

• Aug 2010 - Aug 2010

The Novartis International Biotechnology Leadership Camp (BioCamp) is a pioneering two-day seminar that brings the biotechnology sector closer to talented students from top universities around Egypt. The Novartis International Biotechnology Leadership Camp (BioCamp) is a pioneering two-day seminar that brings the biotechnology sector closer to talented students from top universities around Egypt.

Clinical Pharmacist intern

• Jan 2010 - Feb 2010

“Oncology pharmaceutical care” & “Toxicity monitoring” Clinical Pharmacy workshop “Oncology pharmaceutical care” & “Toxicity monitoring” Clinical Pharmacy workshop

Trainee in Cytogenetic laboratory

• Aug 2009 - Aug 2009

Summer Internship

• Jul 2009 - Aug 2009

Drug Design Internship Drug Design Internship

Summer Trainee

• Jul 2009 - Jul 2009