Experteer OverviewIn this role you lead the risk-based monitoring approach for clinical studies and programs at PSI, ensuring patient safety and data integrity. You will guide the RBM implementation, select and set up monitoring platforms, and manage study-level risk processes with cross-functional teams. You'll present analyses to study teams and clients, and shape risk management plans and SDV strategies. This is a frontline opportunity to drive scalable monitoring solutions in a fast-growing CRO, influencing proposals and client outcomes.Retribuzione / BenefitsLead initial and ongoing study risk managementParticipate in selection and setup of the RBM platformPerform Centralized Monitoring for a study including KRIs, statistical analyses and quality tolerance limitsPresent Centralized Monitoring results to study teams and clients; manage cross-functional issuesDevelop and review study-specific monitoring plansSet up and manage targeted SDV and monitoring strategy for a studySet up and manage Central Data Review activities in a studyContribute to proposals and bid defense meetings with RBM informationCommunicate study challenges to Clinical Data Science and devise data-driven solutionsResponsabilitàCollege/University degree or equivalent combination of education, training and experienceClinical Study Lead/Manager experienceStrong communication & presentation skillsLeadership and ability to work independentlyCentralized Monitoring experience is a plusCritical thinking and analytical skillsAbility to work with complex data and provide insight into risk reports and trendsAbility to adapt to changing circumstances and learn quicklyKnowledge of the process and functions in clinical trials, ability to understand the protocol and study-associated risksFull working proficiency in English (Italian proficiency is a plus)Proficiency in MS Office applications, Excel skills
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