01 ago - Italia
Experteer Italy
Experteer OverviewIn this role you support the clinical research team to run studies in line with GCP, SOPs, and protocols, while respecting budgets and timelines. You own startup activities and document management, ensuring regulatory submissions and site contracts are handled efficiently. You will maintain trial documentation, CTMS updates, and vendor coordination, contributing to audits and reporting. You join a global, collaborative environment that values courage, accountability, and inclusivity to advance clinical research.Retribuzione / BenefitsOversee startup activities and regulatory submissions at national and international levels under PM oversightManage ISF preparation and TMF setup/maintenance under PM oversightMaintain relationships with Ethics Committees and Competent AuthoritiesSupport sites/vendors invoicing management and trackingCollaborate on weekly/monthly project reports and update CTMS and trackersSupport CRAs activities follow-up and document translation as neededParticipate in internal, client/sponsor, scientific meetings and auditsPerform additional duties as assignedResponsabilitàGraduation in scientific/health fieldExperience in clinical research (CROs, Pharma, or academic/hospital)Good knowledge of ICH GCP and applicable regulationsUnderstanding of Clinical Research and Regulatory/Ethical requirementsEnglish proficiencyMS Office Suite proficiencyStrong organizational, multi-tasking, and time management skillsStrong analytical, communication, and interpersonal skills with customer service orientation
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