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Job Description & How to Apply Below
This is a chance to impact patient‑centric development within a global biotech environment.
Retribuzione / Benefits 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 life cycles 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 GCDCoordinate external partners (CROs, data providers, registries, vendors) for initiatives
Support vendor selection, onboarding, oversight and performance monitoring under GCP, GVP, and local regulations
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
Responsabilità
At 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 English Familiarity with study design, planning tools and principles
Knowledge of RWE/RWD regulatory framework, ICH/GCP and company SOPsBudget planning and administrative management experience
Experience with documental archiving and management
Requisiti fondamentalipensionprivate medical insurancewellbeing programmeflexible benefits programmerestaurant voucher/ticketcomprehensive relocation support
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