In this role you will lead end-to-end execution of clinical innovation and real-world evidence (RWE) projects within Global Clinical Development. You will collaborate with cross-functional teams to translate strategies into practical plans, ensuring quality, compliance, and timely delivery. The position focuses on secondary data use, RWE, epidemiology, and database-driven evidence across geographies. You will shape innovations and support integration into ongoing programs, contributing to scientific communications and process improvements. This is a chance to impact patient-centric development within a global biotech environment.Candidarsi per questo ruolo è facile. Scorra verso il basso e faccia clic su "Candidati" per essere preso/a in considerazione per questa posizione.pensionprivate medical insurancePlan, coordinate and deliver clinical innovation and RWE projects within governance frameworksOperate on RWE, epidemiology, and database-driven evidence projects aligned with approved strategiesTranslate concepts into actionable project plans with feasibility and scalability in mindSupport implementation of approved innovation initiatives within development programsParticipate in Integrated Clinical Team activities to provide operational inputTranslate strategic requirements into timelines, resource plans and deliverablesEnsure cross-functional information flow among stakeholdersCoordinate RWE studies and data collection across product lifecycles and geographiesSupport protocol development and study design with Clinical Evidence & Epidemiology and RWE leadershipMaintain timelines, quality,



and budget controls for RWE projectsAct as liaison between Global Medical Affairs and GCDSupport vendor selection, onboarding, oversight and performance monitoring under GCP, GVP, and local regsPrepare and maintain study documentation for Ethics Committees and Regulatory submissionsEnsure eTMF setup and QA, with CRO filing oversight and inspection readinessMonitor project budgets and forecasts; track milestones and risksProvide progress updates to leadership and stakeholdersSupport digital health and patient-centric innovation pilots with Clinical Digital Health & Patient Engagement teamsIntegrate innovation outputs into ongoing development and evidence programsContribute to dissemination of study results and publicationsDrive continuous improvement of innovation and RWE processes and toolsPromote consistent application of governance and standards across projectsAt xysqume least 5 years of experience in the biopharmaceutical industry in Evidence Generation or Clinical Operations Project ManagementMSc degree in scientific disciplines (Biology, Biotechnology, Chemistry, Pharmacy, Chemical and Pharmaceutical Technology)Proficiency in spoken and written EnglishFamiliarity with study design, planning tools and principlesKnowledge of RWE/RWD regulatory framework, ICH/GCP and company SOPsBudget planning and administrative management experienceExperience with documental archiving and managementCross-functional collaborationStrong communication and stakeholder managementProblem solving and attention to detailRWE and epidemiology methodologiesStudy design and planningICH/GCP compliance and regulatory know-how#J-18808-Ljbffr

📌 Clinical Innovation Project Manager (Provincia di Latina)
🏢 Chiesi
📍 Provincia di Latina