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 pRegional Clinical Compliance Country Manager is responsible for ensuring robust oversight of clinical trial compliance at the country and site level. This role applies a risk-based approach to proactively identify, evaluate, and manage compliance risks, ensuring adherence to Good Clinical Practice (GCP), company procedures, and regulatory requirements. The role partners closely with country, regional and global stakeholders to safeguard patient safety, data integrity, and inspection readiness. /p h3Essential Functions of the Job /h3 h3Compliance Subject Matter Expert /h3 ul liServe as the primary point of contact for country teams regarding: ul liGCP requirements /li liCompany and study‑specific procedures /li liGeneral compliance‑related queries /li /ul /li liProvide expert guidance and interpretation of regulations and internal standards to ensure consistent and compliant practices. /li /ul h3Risk‑Based Country and Site Oversight /h3 ul liAnalyze and confirm initial country and site‑specific risks, including identification of critical data and key processes. /li liCommunicate identified country and site trends, lessons learned with Clinical Operations functions for continuous improvement of study conduct compliance. /li liAlign with Global Clinical Compliance on the execution of the Study Health Check Plan at country and site level. /li liLead and support key process reviews through remote desk checks, ensuring alignment with Clinical Research Associated, Clinical Study Managers (CSMs) and respective Line Managers.



/li liIdentify high‑risk sites using a structured, risk‑based approach, including but not limited to: ul liHistorical performance and inspection outcomes /li liPlanned and actual recruitment volumes /li liFeasibility assessments and risks identified during site selection and qualification /li liNon‑compliances identified during the study conduct /li /ul /li liConduct Site Compliance Visits on identified high‑risk sites on a risk‑based approach. /li /ul h3Issue Management Audit and Inspection Support /h3 ul liSupport country teams in identifying, managing, and resolving compliance issues. /li liSupport and manage individual Corrective and Preventive Actions (CAPAs) to ensure issues/deviations are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed in a timely manner. /li liAs needed, support the Regional Clinical Compliance Inspection and Audit Support team, providing input to enable the preparation and conduct of the site audits and inspections. /li /ul h3Core Competencies, Knowledge and Skill Requirements /h3 ul liUnderstanding of clinical trial processes with a thorough knowledge of ICH‑GCP and associated regulatory guidelines /li liAnalytical and problem‑solving skills /li liHigh attention to detail and quality orientation /li liExcellent communication and stakeholder management skills /li /ul h3Communication Interpersonal Skills /h3 ul liExcellent English and Italian written and verbal communication and interpersonal skills /li liExcellent organizational skills and ability to prioritize and multitask /li liAbility to work independently in a multi‑cultural setting and effectively handle multiple priorities in a fast‑paced environment /li /ul h3Education Required /h3 ul liBachelor's degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with a minimum of 5 years of progressive experience in clinical operations roles plus minimum 4 years' experience in a GCP compliance or equivalent role (i.e. quality) is preferred. /li liExperience in oncology global trials is preferred. /li /ul p*exceptions may be made for candidates with equivalent appropriate Clinical Operations experience. /p h3Supervisory Responsibilities /h3 ul liNot applicable /li /ul h3Computer Skills /h3 pPC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) /p h3Other Qualifications /h3 ul liNot applicable /li /ul h3Travel /h3 pup to 20‑30% travel /p pSalary Range Italy: 59,200.00 EUR - 74,000.00 EUR /p h3Global Competencies /h3 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 /li liEmbraces 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

📌 Regional Clinical Compliance Manager (Italia)
🏢 BeiGene
📍 Italia