Clinical Innovation Project Manager

Chiesi; Bolzano; In loco; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

pension

Private medical insurance

Descrizione del lavoro

Chiesi seeks a senior leader to drive end-to-end clinical innovation and RWE programs within Global Clinical Development. You will coordinate cross-functional teams, ensure regulatory compliance, and translate strategies into actionable plans across geographies.

The role emphasizes secondary data use, epidemiology, and database-driven evidence to support patient-centric development. You will shape innovations, contribute to publications, and help integrate RWE outputs into ongoing programs, with

Competenze

• 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.

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.

Conoscenze

Cross-functional collaboration

Budget planning

Stakeholder management

Communication skills

RWE methodologies

Formazione

MSc in Biological/Pharmaceutical sciences

Descrizione del lavoro

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.

• pension
• private medical insurance
• 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
• 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