Regional Clinical Compliance Optimization Lead

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 pThe Regional Clinical Compliance (RCC) Optimization Lead is responsible for proactively identifying signals, trends, and systemic issues across countries and EMEA region to drive continuous improvement in clinical trial execution and processes. This role plays a key part in translating operational insights into actionable improvements, partnering with Global Clinical Compliance, RBQM (Risk-Based Quality Management), and global process owners to enhance efficiency, compliance, and quality across the organization. Collaborates closely with RCC Inspection Lead and RCC Lead (including Country RCCs as needed). /p h3Essential Functions Of The Job /h3 h3Signal Detection Trend Analysis /h3 ul liIdentify and analyze signals, trends, and systemic issues across EMEA using compliance-generated data, audit findings, inspection outcomes, and operational insights. /li liTranslate aggregated insights into meaningful risk patterns and improvement opportunities. /li liProvide regular reporting and recommendations to stakeholders to support informed decision-making. /li /ul h3Process Improvement Risk Management /h3 ul liPropose and support process improvements based on identified trends and systemic issues. /li liCollaborate closely with RBQM teams to integrate findings into process risk assessment and risk mitigation strategies. /li liEnsure alignment of improvements with GCP requirements, company procedures, and quality standards /li liIdentify areas of additional training and support for preparing and delivering such educational sessions within the EMEA region /li /ul h3Operational Excellence Implementation /h3 ul liSupport regional and country-level process improvement initiatives to enhance efficiency, compliance, and consistency. /li liAct as a liaison between regional/country teams and Global Clinical Compliance and global process owners. /li liFacilitate the regional implementation of improvements identified at global, local or regional levels, ensuring scalability and sustainability. /li liPromote best practice sharing across countries and regions. /li /ul h3Stakeholder Collaboration Influence /h3 ul liPartner cross-functionally with Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams. /li liInfluence stakeholders at multiple levels to drive the adoption of process enhancements. /li liSupport change management activities related to new or updated processes. /li /ul h3Supervisory Responsibilities /h3 pNot applicable /p h3Education Required /h3 ul liBachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with 10+ years in clinical research, clinical operations, plus minimum 4 years *experience in a GCP compliance or equivalent role** (i.e. quality) is preferred /li liExceptions may be made for candidates with equivalent appropriate Clinical Operations experience. /li liExperience in data analytics, metrics and KPI management is preferred /li /ul h3Computer Skills /h3 pPC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) /p h3Other Qualifications /h3 ul liExperience with RBQM principles, risk identification, and data-driven decision-making. /li liExperience in process improvement, operational excellence, or quality initiatives. /li liCertification in quality management, clinical research, or process improvement methodologies (e.g., Lean Six Sigma) will be a plus /li liExperience supporting or implementing global process changes /li liExperience in oncology global trials is preferred. /li /ul h3Travel /h3 pup to 10% travel /p h3Salary Range Switzerland /h3 p156,200.00 CHF - 195,200.00 CHF /p 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 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