Country Approval Specialist - FSP - Italy

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ph3Country Approval Specialist - FSP - Italy /h3 pAs 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. /p ul liCoordinate and manage country submissions in line with the global strategy /li liSupport site start-up activities and document collection/review (ICF, FDF, 1572, CVs, etc.) /li liCollaborate with Study Startup, CROs,



Clinical Operations to improve SSU metrics /li liEnsure SSU standards are applied across projects /li liIdentify and escalate potential site activation delays /li liTrack actions and communications to meet study/site timelines /li liResolve escalated issues with CROs/Clinical Operations in partnership with Study Startup /li liProvide feedback on site performance metrics and ensure eTMF accuracy during start-up /li liBS degree or international equivalent /li li2+ years of experience in clinical research Site Start Up /li liAbility to explain data to facilitate data-driven decisions /li liKnowledge of clinical study protocols and essential documents /li liStrong organizational, decision-making, communication, and negotiation skills /li liProficient in Microsoft Excel, Word, and PowerPoint /li liUnderstanding of FDA and ICH-GCP guidelines /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bhhn1