プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Nancy S.に依頼

Egypt

Managing all Clinical Trial material, Ecosystem enhancement, Clinical trial team training,others find them in my profile

プロフィール概要

I'm a Clinical Research Lead with 7 years of experience in many therapeutic ares including Oncology(Solid,Hematology and rare) , infectious Diseases, SMA, Nutrition, Cardiology, Hypertension and Diabetes. I'm professional in managing all clinical trial materials as (Kindly note that these are some examples) : 1) Develop protocol, ICF Country Customization and translation, Systematic reviews ,Medical writing, Submission documents Applications, Cover letter, amendments, and Clinical study related documents, Clinical trial education, development and design of CRFs and other data collection forms, 2) Formation of ( White paper , Survey’s,Reports, Questionnaires). 3) Gap analysis then finding gaps/challenges then bringing out recommendations. 4) Review case report form design for accuracy and adherence to protocol. 5) Clinical study stuff trainings on ICFs, protocols and study related materials. 6) writing clinical study proposals, roadmaps ,amendments ,Cover letters, Submission proposal , protocols, reports, quality checks on Case report forms documentation, Systematic literature reviews. 7) Health authorities package preparation. 8) Clinical study contract and budget formation

専門分野

• ★ Oncology
• ★ Pediatric Oncology
• ★ Infectious Disease
• ☆ Pharmacy
• ☆ Clinical Pharmacy
• ☆ Clinical Trials
• ☆ Neurology
• ☆ Pediatric Neurology
• ☆ Epilepsy & Seizures
• ☆ Headache & Migraine
• ☆ Multiple Sclerosis
• ☆ Pediatric Medicine
• ☆ Women's Health
• ☆ Breast Cancer
• ☆ Ovarian Cancer
• ☆ Men's Health
• ☆ Prostate Cancer
• ☆ Radiation Therapy
• ☆ Chemotherapy
• ☆ Surgical Oncology
• ☆ Gastroenterology & Hepatology
• ☆ Pancreatic Cancer
• ☆ Crohn's Disease
• ☆ Hepatitis
• ☆ Liver Cancer
• ☆ Endocrinology
• ☆ Diabetes
• ☆ Hematology
• ☆ Hematology-Oncology
• ☆ Leukemia & Lymphoma
• ☆ Viral Diseases
• ☆ Epstein-Barr Virus (EBV)
• ☆ Cardiovascular Disease
• ☆ Vascular Medicine
• ☆ Cardiovascular Disease Management
• ☆ Pediatric Cardiology
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Healthcare Administration & Management
• ☆ Hospital & Medical Facility Management
• ☆ Managed Healthcare
• ☆ Medical Practice Management
• ☆ Medical Affairs
• ☆ Occupational Health & Safety
• ☆ Occupational Toxciology
• ☆ Pediatric Endocrinology
• ☆ Neuro-Oncology
• ☆ Pediatric Hematology-Oncology
• ☆ Healthcare Reimbursement

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Business & Legal Writing, Copywriting, Creative Writing, Audio Transcription, Translation

Research Market Research, Meta-Research, Feasibility Study, Gap Analysis, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Operations Consulting

Data & AI Statistical Analysis, Data Visualization, Big Data Analytics, Data Mining, Data Cleaning, Data Processing

Product Development Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Clinical trials consultant

PSI

4月 2023 - 現在

Country and Study startup lead (Clinical Study Lead)

Roche

11月 2022 - 現在

Health Economist and clinical studies consultant

Syreon

6月 2022 - 6月 2023

Senior Clinical Research Associate - CRA III

Children Cancer Hospital - Egypt (CCHE - 57357)

4月 2018 - 9月 2022

学歴

MBA

Arab Academy for Science & Technology - Egypt

9月 2019 - 4月 2022

Clinical Pharmacy

Alexandria University

9月 2012 - 7月 2017

認定資格

• ICH GCP Training Certificate

  Transcelerate Biopharma

  3月 2023 - 現在

• The British Academy of Continuing Medical Education

  Real World Evidence

  3月 2023 - 現在

• Infectious diseases

  St.Jude Cancer Hospital

  1月 2023 - 現在

• immunology course

  Harvard University

  7月 2020 - 現在