Job Description & How to Apply Below
Job Type: Direct Employee
Contract Type:
Permanent
Location:
Italy, IT
Responsibilities
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
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
Fam…
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