Overview In this CRA role, you monitor oncology/hematology trials and ensure adherence to ICH-GCP, local regulations, and SOPs. You collaborate with the Regional Clinical Operations Manager to meet study milestones and maintain data quality. You identify gaps, propose CAPAs, and support site start-up and local expertise. You work across sites to drive timely recruitment, data collection, and inspections readiness, contributing to BeOne’s mission to fight cancer.

ResponsabilidadesPerform feasibility, site identification, selection and evaluation to support site recruitment targetsProvide protocol and study training to sitesConduct pre-study, initiation, routine monitoring, and closeout visits per plan and SOPsCo-monitoring visits when requiredComplete monitoring visit reports per ICH-GCP and BeOne standardsTrack regulatory submissions, recruitment, CRF completion, and data queries at sitesMaintain communication with sites and report progress, issues,



and actions to Clinical OperationsEnsure inspection readiness of studies and sitesCollaborate with Regional Clinical Operations Manager and sites to deliver milestones (startup, recruitment, database analyses, closeout)Attend disease-specific and CRA training; facilitate Study Oversight Visits (SOVs)Evaluate site practices for quality and GCP, escalate issues as neededIdentify site issues and propose CAPA; pursue operating excellence and innovation Requisitos principalesBS in a scientific discipline plus minimum 2 years of monitoring experienceExperience in oncology integral trials preferredUnderstanding of clinical trial processes and ICH guidelines2+ years CRA monitoring experience in pharma or CROExcellent communication and interpersonal skillsStrong organizational, prioritization, and multi-tasking abilitiesFluency in English and Spanish (writing and speaking)Computer skills in Word, Excel, MS Project, PowerPoint, OutlookTravel up to 60%communicationinterpersonal skillsorganizationICH-GCP knowledgeSOP adherenceCRF data management

📌 Clinical Research Associate - BeiGene (Madrid)
🏢 Jobrapido
📍 Madrid