Regional Clinical Compliance Optimization Lead

BeOne Medicines USA; Paesi Bassi; In loco; EUR 107.000 - 134.000; Tempo pieno

Descrizione del lavoro

BeOne Medicines USA seeks an Regional Clinical Compliance Optimization Lead to identify signals, trends, and systemic issues across the EMEA region, driving continuous improvement in trial execution and processes. You will collaborate with Global Clinical Compliance, RBQM, and process owners to enhance efficiency, quality, and compliance, working with RCCs and country teams as needed.

Travel up to 10% is expected; a BS/BA or higher in a scientific field with 10+ years in clinical research and at

Competenze

• 10+ years in clinical research or clinical operations with GCP/compliance experience.
• Experience in data analytics, metrics and KPI management is preferred.
• RBQM principles and data-driven decision making.
• Certification in quality management or clinical research is a plus.
• Experience supporting or implementing global process changes; travel up to 10%.

Mansioni

• Identify signals, trends, and systemic issues across the EMEA region to drive continuous improvement in trial execution and processes.
• Collaborate with RBQM teams to integrate findings into process risk assessment and mitigation.
• Translate insights into actionable recommendations for stakeholders and drive regional implementation of improvements.
• Act as liaison between regional teams and Global Clinical Compliance and process owners; promote best practice sharing.
• Support change management activities related to new or updated processes.

Conoscenze

Data analytics

Metrics management

KPI management

RBQM principles

Process improvement

Quality initiatives

GCP compliance

Clinical operations

Stakeholder collaboration

Change management

Formazione

Bachelor's degree in scientific/medical/healthcare

Strumenti

MS Office

Descrizione del lavoro

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 m inimum 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.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

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.