Clinical Operations Specialist - Regulatory, Greece

About the role

iQVIA is looking for a Clinical Operations Specialist (Regulatory) based in Greece, working in a hybrid setting. The role is accountable for performance and compliance of assigned protocols in line with ICH/GCP, country regulations, sponsor policies, quality standards and adverse event reporting requirements. It reports to a line manager and covers budget and finance, country submissions and approvals, and ensuring sites are ready.

Key responsibilities

• Own country and site budgets, negotiate and complete Clinical Trial Research Agreements (CTRA), track clinical research payments and reconcile them at study close-out
• Execute and oversee country submissions and approvals, develop local language informed consents and interact with IRB/IEC and the Regulatory Authority
• Manage country deliverables, timelines and results, and contribute to local SOPs
• Coordinate with the project manager, CTA and CRA, and work with headquarters to align country timelines
• Support local vendors and oversee local processes, supply import/export, destruction, filing, archiving, retention and insurance
• Enter and update country data in clinical and finance systems, and own local regulatory and financial compliance
• Influence investigators and partners, and deliver clinical and financial contracts within fair market value
• Lead or contribute to initiatives, act as a subject matter expert and mentor colleagues