Business Area: R&D;, Pharmacovigilance & Regulatory Affairs

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

Familiarity with the RWE/RWD regulatory framework, ICH/GCP and company SOPs

Knowledge of budget planning and administrative management

Experienced in documental archiving and management

Location
The position is based at our headquarters in Parma and offers flexible working arrangements, including both hybrid and predominantly remote options.

Compensation range
The minimum salary for this role is €54.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. This role is eligible to participate in an annual premio scheme, subject to company and individual performance.

Benefits
We offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, ticket restaurant and more.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

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📌 Clinical Innovation Project Manager (Parma)
🏢 Biotecnologie - Farmacia - Chimica
📍 Parma