プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

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☆☆☆☆☆

Dr. Laila A.に依頼

Saudi Arabia

More than 18 years of combined hospital pharmaceutical services, teaching, and research experience. Excellent track rec

プロフィール概要

I have been working in medical research since 2009, I had the opportunity to work in the Pharmaceutical and Medical Research center. I worked as a CRA, Research Project Manager as well as an academic teacher in pharmaceutical and research courses. My roles included Sites management, starting from selection, passing by Onsite Monitoring, till Sites closeout with all associated activities for each phase. Research Scientific Review Office, prepare the evaluation reports for all applications/ proposals reviewed and recruit qualified reviewers based on scientific and technical qualifications.Then I was involved in People management, Budgets, Contracting, Payments, and Shipment logistics including Import and Export as well as quality oversight. Design, development, implementation, and maintenance of each clinical trial. Conducting clinical trials in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets. Development and preparation of Clinical Protocols, assuring that Investigator’s Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs) are completed and followed. Directs the development of clinical operations quality systems, including SOPs, Develops and ensures that all study-related documents are compiled and completed as required. (e.g., Monitoring Plan, internal and external resources, Study Reference Manual, Laboratory Manual, Pharmacy Manual, CRF Completion Guideline, among others) and are compliant with SOPs and GCP/ICH/regulatory guidelines. Excellent literature research and writing skills, research proposal evaluations, and advisory board committees. Highly experienced and have published in high impact journals.

専門分野

• ☆ Biostatistics
• ☆ Child Development
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ Medicinal Chemistry
• ☆ Drug Design
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Human Biology
• ☆ Endocrinology
• ☆ Diabetes
• ☆ Infectious Disease
• ☆ Viral Diseases
• ☆ COVID-19
• ☆ Antibiotic Resistance Research
• ☆ Antibiotic Stewardship
• ☆ Medical Education
• ☆ Continuing Medical Education (CME)
• ☆ Public Health
• ☆ Epidemiology
• ☆ Disease Control And Prevention
• ☆ E-Health & Telemedicine
• ☆ Intensive Care Medicine
• ☆ Regulatory Affairs
• ☆ Medical Terminology
• ☆ Medical Sciences
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ User Research
• ☆ Quantitative User Research
• ☆ Feasibility Studies
• ☆ Literature Search
• ☆ Presentation Design
• ☆ Instructional Webinars
• ☆ Continuing Medical Education (CME) Training
• ☆ Skills Training
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Healthcare Communications
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ Case Studies
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Course Content Writing
• ☆ Grant Writing

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing

Research Market Research, Feasibility Study, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Operations Consulting, Financial Consulting

Data & AI Statistical Analysis, Data Cleaning, Data Processing

職務経験

Clinical Research Assistant

Clinical Research Assistant

1月 2018 - 現在

Senior Project Manager Healthcare

Senior Project Manager Healthcare

6月 2010 - 6月 2022

学歴

Master in Nanoscience

Alfaisal University - Saudi Arabia

6月 2016 - 6月 2018

Bachelor in Pharmacy

King Saud Univrsity

9月 1993 - 6月 1998

認定資格

• SOCRA

  SOCRA

  9月 2015 - 現在

• Master degree

  Alfaisal University

  8月 2016 - 6月 2018