14 set
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Chiesi
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Pordenone
Overview
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.
Retribuzione / Benefits
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- restaurant voucher/ticket
- comprehensive relocation support
Responsabilità
- Plan, coordinate and deliver clinical innovation and RWE projects within governance frameworks
- Operate on RWE, epidemiology, and database-driven evidence projects aligned with approved strategies
- Translate concepts into actionable project plans with feasibility and scalability in mind
- Support implementation of approved innovation initiatives within development programs
- Participate in Integrated Clinical Team activities to provide operational input
- Translate strategic requirements into timelines, resource plans and deliverables
- Ensure cross-functional information flow among stakeholders
- Coordinate RWE studies and data collection across product lifecycles and geographies
- Support protocol development and study design with Clinical Evidence & Epidemiology and RWE leadership
- Maintain timelines, quality, and budget controls for RWE projects
- Act as liaison between Global Medical Affairs and GCD
- Coordinate external partners (CROs, data providers, registries, vendors) for initiatives
- Support vendor selection, onboarding, oversight and performance monitoring under GCP, GVP, and local regs
- Serve as day-to-day operational contact for vendors
- Prepare and maintain study documentation for Ethics Committees and Regulatory submissions
- Ensure eTMF setup and QA, with CRO filing oversight and inspection readiness
- Monitor project budgets and forecasts; track milestones and risks
- Provide progress updates to leadership and stakeholders
- Support digital health and patient-centric innovation pilots with Clinical Digital Health & Patient Engagement teams
- Integrate innovation outputs into ongoing development and evidence programs
- Contribute to dissemination of study results and publications
- Drive continuous improvement of innovation and RWE processes and tools
- Promote consistent application of governance and standards across projects
Requisiti fondamentali
- At least 5 years of experience in the biopharmaceutical industry in Evidence Generation or Clinical Operations Project Management
- MSc degree in scientific disciplines (Biology, Biotechnology, Chemistry, Pharmacy, Chemical and Pharmaceutical Technology)
- Proficiency in spoken and written English
- Familiarity with study design, planning tools and principles
- Knowledge of RWE/RWD regulatory framework, ICH/GCP and company SOPs
- Budget planning and administrative management experience
- Experience with documental archiving and management
- Cross-functional collaboration
- Strong communication and stakeholder management
- Problem solving and attention to detail
- RWE and epidemiology methodologies
- Study design and planning
- ICH/GCP compliance and regulatory know-how
📌 Clinical Innovation Project Manager (Pordenone)
🏢 Chiesi
📍 Pordenone