OverviewScopra esattamente quali competenze, esperienze e qualifiche sono necessarie per avere successo in questo ruolo prima di candidarsi.In this role you coordinate the operational management of assigned clinical projects to advance Chiesi's pipeline in line with medical standards.
You act as the primary liaison to CROs, providers, and internal stakeholders, ensuring study quality, timelines, and budget adherence.
You play a key part in study design input and risk management, supporting the execution and reporting of clinical data.
This position offers exposure to a globally distributed R&D; team and meaningful impact on patient-focused drug development.Retribuzione / Benefitspensionprivate medical insurancewellbeing programmeflexible benefits programmerelocation supportremote work optionsResponsabilitàManage 1–3 clinical trials depending on size and phaseOversee Clinical CROs/Providers and serve as primary contact for CROs and internal customersEnsure adherence to scope, timelines, and budgetReview study documents (project plan, monitoring plan, risk management plan, site contracts)
and perform co-monitoring as neededContribute to Study Risk Register and lead clinical risk reviews with cross-functional teamsOversee study eTMF with CTA and coordinate CTS strategy with CTS teamCoordinate preparation of experts/KOL contracts when applicablePrepare and review CSR with Medical Writer; support external/internal presentation of resultsLiaise with CTS for CTS strategy; manage CTS delivery at sitesEnsure SOP compliance and manage CAPA and follow-ups, including auditsProvide clinical operations input during study design and CPAC meetingsBudget preparation and management for ongoing studiesRequisiti fondamentaliAt least 3 years in a similar pharmaceutical roleTrack record of successful planning and execution of at least 5 clinical studies xysqume Degree in Life Sciences or equivalentEnglish fluentKnowledge of clinical study design and biostatisticsFamiliar with planning tools and principlesKnowledge of ICH/GCP and company SOPsKnowledge of GLP for bio-analytical assays (clinical pharmacology)Up-to-date with relevant literatureStrong communication and stakeholder managementCross-functional collaborationAttention to detail and organizational skillsClinical trial management and CRO oversightBudget management for clinical studiesStudy design principles and statistics
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