Profile Details

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USD 500 /hr

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Hire Dr. Oleksiy V.

United States

USD 500 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ☆ 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

Services

• Writing

Writing Clinical Trial Documentation

Work Experience

Associate Director, Regulatory and Start-up

IQVIA (United States)

October 2014 - Present

Associate Director, Site Start-up and Regulatory

Syneos Health

January 2023 - February 2023

Education

Medical Degree (MD)

National Medical University O.O. Bogomolets - Ukraine

August 1982 - January 1997

Certifications

• Fundamentals GCP Exam, . May 05, 2018

  Barnett Educational Services

  May 2018 - Present