Regulatory Affairs &
Clinical Trial Start-Up Leader

EU CTR / CTIS / Medical Devices

Regulatory Affairs and Clinical Trial Start-Up professional delivering EU CTR / CTIS submissions, multi-country study activation, stakeholder leadership, and compliant execution across Europe.

βœ“ EU Experience 🌐 Multi-country Delivery β™Ÿ Sponsor / CRO Background
● Available for New Opportunities πŸ“ Open to Relocation Across EU
Professional portrait of Ioannis Papadopoulos

Regulatory Affairs

CTA, CTIS, submissions, lifecycle maintenance, authority liaison

Clinical Start-Up

Feasibility, activation, timelines, country execution

ICF Expertise

ICF authoring, review, translations, local adaptation

EU MDR

Technical documentation, device compliance, strategy

Leadership

Client ownership, matrix teams, escalation management

Global Delivery

Cross-country execution across EU markets

Professional Experience

Senior Site Activation Lead | ICON PLC

  • Led site activation across 10+ EU countries for complex global studies.
  • Managed sponsor relationships across multiple concurrent studies.
  • Improved start-up delivery timelines by 20% through proactive planning and risk mitigation.
  • Maintained 98% compliance in key start-up metrics including Activate, eTMF, and training.

Site Activation Manager | Syneos Health

  • Oversaw study start-up strategy and execution for 15+ EU clinical studies.
  • Coordinated submissions, vendors, and internal/external stakeholders across multiple countries.
  • Delivered 95% of study milestones on or ahead of aggressive timelines.

Site Activation Manager | IQVIA RDS

  • Managed site selection, feasibility, and activation activities across therapeutic areas.
  • Led activation efforts in 8+ countries and ensured country-level execution and alignment.
  • Reduced activation cycle time by 15% through process optimization.

Regulatory Start-Up Specialist | IQVIA RDS / Boston Scientific

  • Managed CTA and Ethics Committee submissions for medical device studies.
  • Submitted and maintained regulatory documentation across 10+ jurisdictions.
  • Ensured full compliance with local regulations and authority requirements.
  • Supported cross-functional teams to achieve regulatory approval and site activation.

Clinical Process Associate | IQVIA RDS

  • Managed clinical trial documentation and supported regulatory start-up activities.
  • Ensured accuracy, completeness, and compliance of essential documents.

Core Competencies

  • EU CTR / CTIS
  • Clinical Trial Applications (CTA)
  • Regulatory Affairs Strategy
  • Clinical Start-Up (SSU / RSU)
  • ICH-GCP Compliance
  • Ethics Committee / Authority Submissions
  • Cross-Functional Leadership
  • Vendor Management
  • Risk & Escalation Management
  • EU MDR / Medical Devices
  • eTMF / CTMS / Regulatory Systems
  • Multi-country Trial Delivery

Education

Master of Pharmacy

Comenius University, Bratislava (Slovakia)

Aesthetics-Cosmetology Diploma

Technological Educational Institute, Thessaloniki (Greece)

Dental Technology Diploma

Pasteur Institute, Thessaloniki (Greece)

Recognition

  • SPARK Award – Partnership Excellence (ICON, 2025)
  • Recognized for leadership and proactive problem solving
  • Praised by clients and managers for delivery excellence
  • Trusted mentor and strong team contributor

References

Senior CRO / Pharma references available upon request.

Certifications / Professional Development

Open to Opportunities

Regulatory Affairs Manager Clinical Start-Up Manager CTIS / CTA Specialist