BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:The 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 plusEssential Functions of the job: Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets•Provides protocol and related study training to assigned sites.•Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs•Conducts co-monitoring visits, if required•Completes monitoring visit reports in accordance with ICH-GCP, BeiGene standardsand 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 innovationEducation Required: Sciences degreeMaster in Monitoring and Management of Clinical TrialsSupervisory Responsibilities: N/AComputer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and OutlookOther Qualifications: Travel: YesSalary Range EU: 41,400.00 EUR - 51,800.00 EURGlobal CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve general 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 ClarityWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.SummaryLocation: Spain RemoteType: Full time

📌 Clinical Research Associate (España)
🏢 Beigene
📍 España