General DescriptionThe CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology / hematology clinical trials within the assigned region.The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.Identify gaps and areas for improvement and propose CAPA.Supports start-up and provides local expertise.SSU experience is considered a plusCRA activitiesPerform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targetsProvides protocol and related study training to assigned sites.Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPsConducts co-monitoring visits, if requiredCompletes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOPManages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical OperationsEnsure inspection readiness of the study and sitesCollaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)Attends disease indication project specific training and general CRA training as requiredFacilitate Study Oversight Visits (SOVs), site audits and / or inspections, as requiredEvaluates the quality and integrity of site practices – escalating quality and / or GCP issues with Investigators and internal team as appropriate.Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.Education Required :BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.Experience in oncology global trials preferredOther Qualifications :Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelinesAt least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industryExperience in oncology / hematology trials preferredExcellent communication and interpersonal skillsExcellent organizational skills and ability to prioritize and multi-taskFluent in English & Italian (writing and speaking)Computer Skills : Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and OutlookTravel : up to 60%Global CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking / Data AnalysisFinancial ExcellenceCommunicates with Clarity
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