プロフィール詳細

プロジェクトを作成

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Dr. Oleksiy V.に依頼

United States

Clinical research expert with 20 years of experience in clinical trials, including 18 years in Regulatory and Start-up

プロフィール概要

Experienced clinical research leader with 20 years of experience in clinical trials, including 18 years in Regulatory and Start-Up (RSU). Demonstrated success in global project oversight, regulatory submissions, site activation management and project delivery across diverse regions). Strong analytical, project management, and communication skills with a consistent record of delivering results in complex, multi-regional studies. Currently serving as a Global RSU Lead, Global Maintenance Lead, and Site Activation Manager, Oleksiy oversees regulatory and start-up delivery for 27 multicenter clinical trials across Western Europe, EMEA, APAC, LATAM, and North America. His role includes strategic planning, regulatory oversight, stakeholder engagement, and ensuring site activation readiness in alignment with global timelines and compliance standards.

専門分野

• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Human Biology
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Regulatory Affairs
• ☆ Medical Equipment & Supplies

サービス

• Writing

Writing Clinical Trial Documentation

職務経験

Associate Director, Regulatory and Start-up

IQVIA (United States)

10月 2014 - 現在

Associate Director, Site Start-up and Regulatory

Syneos Health

1月 2023 - 2月 2023

学歴

Medical Degree (MD)

National Medical University O.O. Bogomolets - Ukraine

8月 1982 - 1月 1997

認定資格

• Fundamentals GCP Exam, . May 05, 2018

  Barnett Educational Services

  5月 2018 - 現在