Clinical Innovation Project Manager
Chiesi
ppIn 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. /pullipension /liliprivate medical insurance /liliPlan, coordinate and deliver clinical innovation and RWE projects within governance frameworks /liliOperate on RWE, epidemiology, and database-driven evidence projects aligned with approved strategies /liliTranslate concepts into actionable project plans with feasibility and scalability in mind /liliSupport implementation of approved innovation initiatives within development programs /liliParticipate in Integrated Clinical Team activities to provide operational input /liliTranslate strategic requirements into timelines, resource plans and deliverables /liliEnsure cross-functional information flow among stakeholders /liliCoordinate RWE studies and data collection across product lifecycles and geographies /liliSupport protocol development and study design with Clinical Evidence Epidemiology and RWE leadership /liliMaintain timelines, quality, and budget controls for RWE projects /liliAct as liaison between Global Medical Affairs and GCD /liliSupport vendor selection, onboarding, oversight and performance monitoring under GCP, GVP, and local regs /liliPrepare and maintain study documentation for Ethics Committees and Regulatory submissions /liliEnsure eTMF setup and QA, with CRO filing oversight and inspection readiness /liliMonitor project budgets and forecasts; track milestones and risks /liliProvide progress updates to leadership and stakeholders /liliSupport digital health and patient-centric innovation pilots with Clinical Digital Health Patient Engagement teams /liliIntegrate innovation outputs into ongoing development and evidence programs /liliContribute to dissemination of study results and publications /liliDrive continuous improvement of innovation and RWE processes and tools /liliPromote consistent application of governance and standards across projects /liliAt least 5 years of experience in the biopharmaceutical industry in Evidence Generation or Clinical Operations Project Management /liliMSc degree in scientific disciplines (Biology, Biotechnology, Chemistry, Pharmacy, Chemical and Pharmaceutical Technology) /liliProficiency in spoken and written English /liliFamiliarity with study design, planning tools and principles /liliKnowledge of RWE/RWD regulatory framework, ICH/GCP and company SOPs /liliBudget planning and administrative management experience /liliExperience with documental archiving and management /liliCross-functional collaboration /liliStrong communication and stakeholder management /liliProblem solving and attention to detail /liliRWE and epidemiology methodologies /liliStudy design and planning /liliICH/GCP compliance and regulatory know-how /li /ulpClinical Innovation Project Manager rovigo, veneto, it /p /p #J-18808-Ljbffr
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