Mag. Ioannis Papadopoulos

Open to new opportunities in DACH region – Regulatory Affairs / EU CTR / CTIS

Bis 2025, Senior Site Activation Lead, ICON plc
Abschluss: Masters, Comenius University in Bratislava
Bratislava, Slovakia

Fähigkeiten und Kenntnisse

CTIS (Clinical Trials Information System)
EU Clinical Trials Regulation (EU CTR 536/2014)
Study Start-Up (SSU)
Regulatory Affairs
CTIS
Clinical Trial Submissions
CTA Submission
Regulatory Submissions
Regulatory Operations
Regulatory Operations Management
Site Activation
Start-Up Management
Clinical Trial Start-Up
International Project Management
Stakeholder Management
Part I / Part II Documentation
Substantial Modifications
Requests for Information (RFI)
Regulatory Intelligence
Regulatory Compliance
ICH-GCP
Essential Documents
eTMF
CTMS
Informed Consent Forms (ICF)
ICF Localisation
Trial Maintenance
Country Submissions
BfArM
PEI
Ethics Committee Submissions
Clinical Trial Documentation
Quality Management
SOP Management
Audit Support
Regulatory Start-Up (RSU)
EU/EEA submissions
Clinical Trial Applications (CTA)
Ethics submissions / EC submissions
CTIS lifecycle management
TMF management
Vendor Management
Inspection readiness / audit readiness
Country regulatory submissions
Site start-up timelines / metrics
Plain language writing

Werdegang

Berufserfahrung von Ioannis Papadopoulos

  • 2 years and 5 months, Aug 2023 - Dec 2025

    Senior Site Activation Lead

    ICON plc

    Sr. Regulatory startup lead for global interventional and non-interventional studies

  • 1 year and 9 months, Nov 2021 - Jul 2023

    Site Activation Manager

    Syneos Health Commercial Germany GmbH

    Regulatory startup lead for global interventional and non-interventional studies

  • 6 months, May 2021 - Oct 2021

    Site Activation Manager

    IQVIA

    Interventional, Non-interventional and Medical Devices studies

  • 1 year and 5 months, Jan 2020 - May 2021

    Regulatory Startup Specialist

    IQVIA

    Handled startup submissions and regulatory authority interactions in Austria, Germany, and Greece. Negotiated budgets and contracts, and acted as ICF process lead. Prepared submission packs for Austria and Greece; engaged directly with sites and handled contract negotiation

  • 4 years and 3 months, Oct 2015 - Dec 2019

    Clinical Process Associate

    IQVIA

    Served as SPOC (Special Point Of Contact) for ICF adaptation across multiple countries, including the USA, Canada, and EU regions (Greece, Turkey, Switzerland, Poland, Bulgaria, Romania, Ukraine, Denmark, Sweden, Norway). Supported Swissmedic processes via ICF adaptations and regulatory alignment for Switzerland.

Ausbildung von Ioannis Papadopoulos

  • 4 years and 10 months, Sep 2008 - Jun 2013

    Pharmacy

    Comenius University in Bratislava

    Pharmacist (Magister of Pharmacy degree)

  • 6 years and 2 months, Sep 1998 - Oct 2004

    Aesthetics-Cosmetology

    Alexander Technological Educational Institute of Thessaloniki

Sprachen

  • Greek

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C2 (Verhandlungssicher / Muttersprachlich)

  • German

    A1-A2 (Grundkenntnisse)

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