ppBeOne 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. /p h3General Description /h3 ul liCRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. /li liCRA performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/onco-hematology clinical trials within the assigned country/region. /li liMay be assigned to CRA activities or start-up activities, depending on experience and project needs. /li liCRA is responsible for collaborating closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained. /li liCRA identifies gaps and areas for improvement and propose CAPA. /li liCRA supports start-up and provides local expertise. /li /ul pexpertise. /p h3Essential Functions Of The Job /h3 ul liComplete appropriate therapeutic, protocol and clinical research training/CRA training to perform job duties. /li liGain experience in BeOne and study procedures by working with experienced clinical staff. /li liPerform site selection and evaluation, supporting initial list of sites and recruitment targets. /li liProvide protocol and related study training to assigned sites. /li liConduct onsite/remote pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs. /li liConduct co-monitoring visits, if required. /li liCreate and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation, in accordance with ICH-GCP, BeOne standards and SOPs. /li liManage sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution /li liEnsure copies/originals (as required)



site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements. /li liEnsure inspection readiness of the study and sites /li liEstablish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations. /li liCollaborate with Country and Regional Clinical Study Managers and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.) /li liFacilitate Study Compliance Visits (SCVs), site audits and/or inspections, as required /li liEvaluate the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate. /li liAnticipate 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. /li liMentor junior staff (Associate CRA and CRA). /li liAct as the escalation point person for CRA(s) with site-related issues and concerns. /li liMay review visits reports, following-up on issue resolution and communicating with the Country/Regional Clinical Study Manager on significant risk identified and action proposed. /li liMay serve as subject matter expert for clinical operations, country regulations and monitoring-related activities. /li /ul h3Supervisory Responsibilities /h3 ul liMentor/Buddy for junior CRAs. /li liActs as the escalation point person for CRAs with site-related issues and concerns.



/li liMay serve as subject matter expert for clinical operations and CRA-related activities; /li /ul h3Education Required /h3 ul liBS in a scientific or healthcare discipline preferred and at least 3 - 5 years of monitoring experience. /li liExperience in oncology/onco-hematology global trials preferred /li /ul h3Other Qualifications /h3 ul liAdvanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and associated regulatory guidelines. /li liAt least 3 - 5 years of (CRA) monitoring experience in the pharmaceutical or CRO industry. An equivalent combination of education, training, and experience may be considered. /li liExperience in oncology/onco-hematology trials preferred /li liExcellent communication and interpersonal skills /li liAbility to establish and maintain effective working relationships with coworkers, managers, and other internal/external stakeholders as applicable /li liExcellent organizational and problem-solving skills and ability to prioritize and multitask /li liEffective time management skills /li liWritten and verbal communication skills, including a good command of the English language and Italian /li /ul h3Computer Skills /h3 pEfficient in Microsoft Word, Excel, PowerPoint, Outlook, and use of a laptop computer and iPhone. /p h3Travel /h3 pup to 60% /p pSalary Range EU: 51,500.00 EUR - 64,400.00 EUR /p h3Global Competencies /h3 pWhen 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. /p ul liFosters Teamwork /li liProvides and Solicits Honest and Actionable Feedback /li liSelf-Awareness /li liActs Inclusively /li liDemonstrates Initiative /li liEntrepreneurial Mindset /li liContinuous Learning /liliEmbraces Change /li liResults-Oriented /li liAnalytical Thinking/Data Analysis /li liFinancial Excellence /li liCommunicates with Clarity /li /ul pWe 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. /p /p #J-18808-Ljbffr

📌 Senior Clinical Research Associate (Milano)
🏢 BeOne Medicines
📍 Milano