Clinical Innovation Project Manager

6 ore fa

Siena, Tuscany, Italia Chiesi Tempo pieno
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