Global Clinical Innovation & RWE Project Lead

Chiesi; La Spezia; In loco; EUR 70.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Descrizione del lavoro

Chiesi is seeking an experienced professional to lead end-to-end execution of clinical innovation and real-world evidence projects within Global Clinical Development. You will collaborate with cross-functional teams to translate strategies into practical plans, ensuring quality, compliance, and timely delivery.

Focus on secondary data use, epidemiology, and database-driven evidence across geographies, shaping innovations and supporting integration into ongoing programs.

Competenze

• At least 5 years of experience in the biopharmaceutical industry in Evidence Generation or Clinical Operations Project Management.
• MSc degree in Biology, Biotechnology, Chemistry, Pharmacy or related field.
• Proficiency in spoken and written English.
• Knowledge of RWE/RWD regulatory framework, ICH/GCP and company SOPs.
• Budget planning and administrative management experience.
• Strong cross-functional collaboration and stakeholder management.
• Experience with study design and planning.

Mansioni

• 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.
• Support vendor selection, onboarding, oversight and performance monitoring under GCP, GVP, and local regs.
• 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.
• At least 5 years of experience in the biopharmaceutical industry in Evidence Generation or Clinical Operations Project Management.

Conoscenze

Project Management

RWE & Epidemiology

Cross-functional Collaboration

English Proficiency

Budget & Planning

Regulatory Knowledge (ICH/GCP)

Formazione

MSc in Biological/Pharmaceutical Sciences

Strumenti

Planning tools

Descrizione del lavoro

Chiesi is seeking an experienced professional to lead end-to-end execution of clinical innovation and real-world evidence projects within Global Clinical Development. You will collaborate with cross-functional teams to translate strategies into practical plans, ensuring quality, compliance, and timely delivery.

Focus on secondary data use, epidemiology, and database-driven evidence across geographies, shaping innovations and supporting integration into ongoing programs.