Clinical Innovation Project Manager

Chiesi; Teramo; In loco; EUR 85.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Descrizione del lavoro

Chiesi in Italy seeks a leader to drive clinical innovation and real-world evidence projects within Global Clinical Development. You will translate strategies into actionable plans across geographies, ensuring quality, compliance and timely delivery.

The role focuses on secondary data use, epidemiology and database-driven evidence, shaping innovations and supporting integration into ongoing programs, contributing to scientific communications and improvements.

Competenze

• MSc degree in biological or pharmaceutical sciences.
• 5+ years in Evidence Generation or Clinical Operations PM in biopharma.
• Proficiency in written and spoken English.
• Knowledge of ICH/GCP and regulatory SOPs.
• Budget and vendor management experience.

Mansioni

• Plan, coordinate and deliver RWE projects within governance frameworks.
• Coordinate RWE studies across geographies and lifecycles.
• Support eTMF setup and QA, CRO oversight and regulatory submissions.
• Monitor project budgets, milestones and risks.
• Disseminate study results and publications.

Conoscenze

RWE methods

Epidemiology

Clinical Ops

Study design

Project management

Cross-functional collaboration

Budget planning

GCP compliance

Regulatory knowledge

Communication

Formazione

MSc in Sciences

Strumenti

Planning tools

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