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. The CRA activities include performing feasibility, site identification, selection and evaluation, supporting the 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, BeOne Medicines standards and SOP. Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. Establishes regular lines of communication with sites and reports site progress, issues and proposed actions to Clinical Operations. Ensures inspection readiness of the study and sites. Collaborates with the 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 required. Facilitates Study Oversight Visits (SOVs), site audits and/or inspections, as required. Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate. Anticipates and identifies site issues; proposes corrective andpreventative actions; identifies gaps and utilizes opportunities. Constantly strives for operating excellence, questions status-quo, and promotes innovation.Potrebbe essere proprio lei il candidato/la candidata ideale per questo lavoro. Legga tutte le informazioni associate e invii la sua candidatura.Education Required:BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.Experience in oncology global trials preferred.Other 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 Outlook.Travel:Up to 60%.Salary Range EU:44,800.00 EUR - 56,000.00 EUR.Global Competencies:Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityEqual Opportunity Statement:We 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.About BeOne:BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them.Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.For more information, please visit the link to explore job opportunities in China Mainland. xysqume China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit#J-18808-Ljbffr

📌 Clinical Research Associate (Romano di Lombardia)
🏢 BeiGene
📍 Romano di Lombardia