Senior Clinical Study Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78fzos

Experteer OverviewAs Clinical Study Manager you will lead end-to-end operational delivery of complex trials within a global, cross-functional team. Non aspetti a candidarsi dopo aver letto questa descrizione: per questa possibilità è previsto un elevato volume di candidature. You drive RBQM-based quality, patient safety, and regulatory compliance to ensure on-time, within-budget study outcomes with inspection readiness. You collaborate across internal functions and external partners to translate global protocols into effective execution. This role offers meaningful impact through shaping trial performance and ensuring high data integrity in a fast-moving development environment.Retribuzione / BenefitsLead planning and execution of complex interventional trials from start-up to close-out with RBQM throughoutEnsure alignment with global study strategy, timelines, and milestones defined by the Lead Clinical Study ManagerAct as an accountable member of the Clinical Trial Team, contributing to decisions and issue resolutionProvide proactive risk-based oversight,



identify trends and mitigate quality signalsChampion quality by design with emphasis on patient safety and data integrityMaintain TMF completeness and inspection readiness across the study lifecycleSupport audit and inspection preparedness and follow-up activitiesServe as primary contact for CROs and external vendors, managing quality and contractual deliveryMonitor vendor performance via KPIs and RBQM outputsCoordinate activities across Data Management, Biostatistics, Drug Supply, Pharmacovigilance, Regulatory Affairs, and othersContribute to the preparation/review of key documents (protocol sections, ICFs, CSRs) and support data review/cleaning for timely database lockAssist in regulatory document preparation (e.g., IB, ASRs) and results posting in public xrdztoy databasesResponsabilità4-6 years of clinical trial experience in pharma, biotech, or CRO environmentsHands‐on experience managing complex global inter

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78fzos