Country Approval Specialist - FSP - Italy

Country Approval Specialist - FSP - Italy As a Country Approval Specialist, you will help align country submissions with the global strategy while supporting site start-up processes. You will collaborate with internal and external teams to ensure timely site activation and adherence to regulatory standards. The role focuses on coordinating submissions, reviewing essential documents, and improving SSU metrics in a global, cross-functional environment. This is an opportunity to shape efficient start-up workflows at scale and contribute to clinical program success. You will work with diverse teams to drive timely, compliant country approvals and elevate overall study start-up performance.

Coordinate and manage country submissions in line with the global strategy

Support site start-up activities and document collection/review (ICF, FDF, 1572, CVs, etc.)

Collaborate with Study Startup, CROs, Clinical Operations to improve SSU metrics

Ensure SSU standards are applied across projects

Identify and escalate potential site activation delays

Track actions and communications to meet study/site timelines

Resolve escalated issues with CROs/Clinical Operations in partnership with Study Startup

Provide feedback on site performance metrics and ensure eTMF accuracy during start-up

BS degree or international equivalent

2+ years of experience in clinical research Site Start Up

Ability to explain data to facilitate data-driven decisions

Knowledge of clinical study protocols and essential documents

Strong organizational, decision-making, communication, and negotiation skills

Proficient in Microsoft Excel, Word, and PowerPoint

Understanding of FDA and ICH-GCP guidelines

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