Clinical Innovation Project Manager (Latina)

Clinical Innovation Project Manager (Latina)

14 set
|
Chiesi
|
Latina

14 set

Chiesi

Latina

OverviewIn 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 / Benefitspension
private medical insurance
wellbeing programme
flexible benefits programme
restaurant voucher/ticket
comprehensive relocation support
ResponsabilitàPlan, 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 fondamentaliAt 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 (Latina)
🏢 Chiesi
📍 Latina

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