Clinical Innovation Project Manager

Chiesi; Spoleto; In loco; EUR 47.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pensione

Assicurazione sanitaria privata

Programma benessere

Flessibilità oraria

Relocation support

Assistenza fiscale per colleghi esteri

Descrizione del lavoro

Chiesi Ricerca & Sviluppo cerca un/una professionista con almeno 5 anni di esperienza in Evidenza Generazione o Clinical Operations per guidare progetti di innovazione e RWE in ambito Biopharma.

La posizione è basata a Parma e offre opzioni di lavoro ibrido o remoto, insieme a opportunità di formazione, pacchetto retributivo competitivo e benefici.

Competenze

• Almeno 5 anni di esperienza nell'industria biopharmaceutica in Evidenza Generazione o gestione di progetti clinici
• Conoscenza di principi di studio design, pianificazione e principi
• Familiarità con framework regolatori RWE/RWD, ICH/GCP e SOP aziendali

Mansioni

• Esecuzione end-to-end di progetti di innovazione e di RWE in linea con le strategie approvate
• Coordinamento di team cross-funzionali e fornitori esterni in conformità GCP/GVP
• Pianificazione operativa, controllo di tempi, qualità e budget dei progetti
• Supporto nelle attività di integrazione di innovazione in programmi di sviluppo clinico

Conoscenze

English proficiency

Formazione

MSc degree in scientific disciplines (Biology, Biotechnology, Chemistry, Pharmacy, Chemical and Pharmaceutical Technology)

Descrizione del lavoro

Descrizione dell’offerta di lavoro

About usChiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy.

Continui a leggere per scoprire di cosa avrà bisogno per avere successo in questa posizione, incluse competenze, qualifiche ed esperienza.

More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

This is what you will do

End to end execution of assigned innovation and initiatives, translating straegies and study designs on time, quality, and compliant delivery across programs, therapeutic areas and geographiesAd hoc member of Integrated Clinical Teams, supporting cross functional alignment among Clinical Development, Clinical Evidence & Epidemiology, Digital Health, Medical Affairs & Patient EngagementYou will be responsible for Operational planning, coordination and delivery of clinical innovation and real world evidence (RWE) projects on secondary data use, within the Global Clinical Development governance frameworkExecute assigned clinical innovation, RWE, epidemiology, and database driven evidence projects in line with approved evidence strategies and pipeline prioritiesTranslate approved concepts, protocols, and innovation designs into operational project plans, ensuring feasibility, scalability, and complianceSupport implementation of approved innovation initiatives within ongoing development programsParticipate in Integrated Clinical Team (ICT) activities for assigned programs, providing operational input and execution updatesSupport evidence and innovation decision making by translating strategic requirements into practical timelines, resource plans, and deliverablesEnsure coordination and information flow across involved functions and stakeholdersCoordinate and manage RWE studies and secondary data collection initiatives (regulatory and non regulatory) across the product lifecycle and geographies, under appropriate scientific oversightSupport protocol development, study design finalization, and implementation of RWE studies in collaboration with Clinical Evidence & Epidemiology and RWE leadershipEnsure operational control of timelines, quality, and budget for assigned RWE projectsActs as connector and integration element between Global Medical Affairs and GCDCoordinate cross functional study teams and external partners (CROs, data providers, registries, technology vendors) involved in innovation and RWE data driven initiativesSupport vendor selection, onboarding, oversight, and performance monitoring in compliance with GCP, GVP, and applicable local regulationsAct as a day to day operational contact for vendors and service providers supporting assigned projectsSupport preparation, collection, and maintenance of study documentation required for Ethics Committees and Regulatory Authority submissions for RWE and innovation projectsEnsure appropriate eTMF set up, maintenance, quality checks, and reconciliation for assigned studies, including oversight of CRO filing activitiesEnsure inspection ready documentation in alignment with internal standards and regulatory requirementsMonitor project budgets, invoices, and forecasts, ensuring alignment between contracted activities and actual costsTrack milestones, risks, and dependencies, escalating issues as needed to ensure delivery commitments are metProvide regular progress updates and performance reporting to project leadership and stakeholdersSupport the execution of digital health & patient centric innovation initiatives, including pilots & operational roll outs, in coordination with Clinical Digital Health & Patient Engagement teamsEnsure integration of innovation outputs into ongoing clinical development and evidence programsContribute to study results dissemination, scientific communications, and publications when requiredSupport continuous improvement of innovation and RWE processes, tools, and ways of working within the Clinical Innovation UnitPromote consistent application of the 'framework and governance in place' aligned operational standards across projects

You will need to have

At least 5 years of experience in biopharmaceutical industry in Evidence Generation or Clinical Operations Project management rolesMSc degree in scientific disciplines (Biology, Biotechnology, Chemistry, Pharmacy, Chemical and Pharmaceutical Technology)Proficiency in spoken and written EnglishExperienced in principles of study design, planning tools and principlesFamiliarity with the RWE/RWD regulatory framework, ICH/GCP and company SOPsKnowledge of budget planning and administrative managementExperienced 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 52.000, 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 bonus scheme, subject to company and individual performance.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

• pension
• private medical insurance
• wellbeing programme
• flexible benefits programme
• tivcket restaurant
• comprehensive healthcare programs
• work-life balance initiatives
• robust relocation support
• tax assistance services for foreign colleagues

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.