Clinical Innovation Project Manager

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

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Job Type: Direct Employee

Contract Type: Permanent

Location: Italy, IT

Responsibilities

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• End to end execution of assigned innovation and initiatives, translating strategies and study designs on time, quality, and compliant delivery across programs, therapeutic areas and geographies
  
• Ad hoc member of Integrated Clinical Teams, supporting cross functional alignment among Clinical Development, Clinical Evidence & Epidemiology, Digital Health, Medical Affairs & Patient Engagement
  
• Operational planning, coordination and delivery of clinical innovation and real world evidence (RWE) projects on secondary data use, within the Global Clinical Development governance framework
  
• Execute assigned clinical innovation, RWE, epidemiology, and database driven evidence projects in line with approved evidence strategies and pipeline priorities
  
• Translate approved concepts, protocols, and innovation designs into operational project plans, ensuring feasibility, scalability, and compliance
  
• Support implementation of approved innovation initiatives within ongoing development programs
  
• Participate in Integrated Clinical Team (ICT) activities for assigned programs, providing operational input and execution updates
  
• Support evidence and innovation decision making by translating strategic requirements into practical timelines, resource plans, and deliverables
  
• Ensure coordination and information flow across involved functions and stakeholders
  
• Coordinate and manage RWE studies and secondary data collection initiatives (regulatory and non regulatory) across the product lifecycle and geographies, under appropriate scientific oversight
  
• Support protocol development, study design finalization, and implementation of RWE studies in collaboration with Clinical Evidence & Epidemiology and RWE leadership
  
• Ensure operational control of timelines, quality, and budget for assigned RWE projects
  
• Acts as connector and integration element between Global Medical Affairs and GCD
  
• Coordinate cross functional study teams and external partners (CROs, data providers, registries, technology vendors) involved in innovation and RWE data driven initiatives
  
• Support vendor selection, onboarding, oversight, and performance monitoring in compliance with GCP, GVP, and applicable local regulations
  
• Act as a day to day operational contact for vendors and service providers supporting assigned projects
  
• Support preparation, collection, and maintenance of study documentation required for Ethics Committees and Regulatory Authority submissions for RWE and innovation projects
  
• Ensure appropriate eTMF set up, maintenance, quality checks, and reconciliation for assigned studies, including oversight of CRO filing activities
  
• Ensure inspection ready documentation in alignment with internal standards and regulatory requirements
  
• Monitor project budgets, invoices, and forecasts, ensuring alignment between contracted activities and actual costs
  
• Track milestones, risks, and dependencies, escalating issues as needed to ensure delivery commitments are met
  
• Provide regular progress updates and performance reporting to project leadership and stakeholders
  
• Support the execution of digital health & patient centric innovation initiatives, including pilots & operational roll outs, in coordination with Clinical Digital Health & Patient Engagement teams
  
• Ensure integration of innovation outputs into ongoing clinical development and evidence programs
  
• Contribute to study results dissemination, scientific communications, and publications when required
  
• Support continuous improvement of innovation and RWE processes, tools, and ways of working within the Clinical Innovation Unit
  
• Promote consistent application of the 'framework and governance in place' aligned operational standards across projects
  

Qualifications

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• At least 5 years of experience in biopharmaceutical industry in Evidence Generation or Clinical Operations Project management roles
  
• MSc degree in scientific disciplines (Biology, Biotechnology, Chemistry, Pharmacy, Chemical and Pharmaceutical Technology)
  
• Proficiency in spoken and written English
  
• Experienced in principles of study design, planning tools and principles
  
• Familiarity with the RWE/RWD regulatory framework, ICH/GCP and company SOPs
  
• Knowledge of budget planning and administrative management
  
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