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The lead is responsible for identifying systemic compliance issues and trends across the EMEA region to drive continuous improvement in clinical trial execution. They will partner with global teams to integrate risk management strategies and facilitate the implementation of process enhancements.
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 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).
Essential Functions of the Job:
Signal Detection & Trend Analysis
Identify and analyze signals, trends, and systemic issues across EMEA using compliance-generated data, audit findings, inspection outcomes, and operational insights.
Translate aggregated insights into meaningful risk patterns and improvement opportunities.
Provide regular reporting and recommendations to stakeholders to support informed decision-making.
Process Improvement & Risk Management
Propose and support process improvements based on identified trends and systemic issues.
Collaborate closely with RBQM teams to integrate findings into process risk assessment and risk mitigation strategies.
Ensure alignment of improvements with GCP requirements, company procedures, and quality standards
Identify areas of additional training and support for preparing and delivering such educational sessions within the EMEA region
Operational Excellence & Implementation
Support regional and country-level process improvement initiatives to enhance efficiency, compliance, and consistency.
Act as a liaison between regional/country teams and Global Clinical Compliance and global process owners.
Facilitate the regional implementation of improvements identified at global, local or regional levels, ensuring scalability and sustainability.
Promote best practice sharing across countries and regions.
Stakeholder Collaboration & Influence
Partner cross-functionally with Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams.
Influence stakeholders at multiple levels to drive the adoption of process enhancements.
Support change management activities related to new or updated processes.
Supervisory Responsibilities: Not applicable
Education Required:
Bachelor’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
*Exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.
** Experience in data analytics, metrics and KPI management is preferred
Computer Skills: PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
Experience with RBQM principles, risk identification, and data-driven decision-making.
Experience in process improvement, operational excellence, or quality initiatives.
Certification in quality management, clinical research, or process improvement methodologies (e.g., Lean Six Sigma) will be a plus
Experience supporting or implementing global process changes
Experience in oncology global trials is preferred.
Travel: up to 10% travel
Salary Range Netherlands: 107,200.00 EUR - 134,000.00 EUR
Global Competencies
When 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.
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.
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