Regional Clinical Compliance Optimization Lead

This is a fully remote position, open to applicants in Netherlands.

📋 Description

• Proactively recognize and evaluate signals, trends, and systemic challenges across the EMEA region utilizing compliance-generated data, audit results, inspection outcomes, and operational insights.

• Convert collective insights into identifiable risk patterns and opportunities for improvement.

• Deliver consistent reporting and recommendations to stakeholders.

• Suggest and assist with process enhancements based on recognized trends and systemic challenges.

• Work in partnership with RBQM teams to incorporate findings into process risk evaluations and mitigation strategies.

• Ensure that improvements align with GCP requirements, company protocols, and quality standards.

• Determine additional training requirements and aid in the preparation and presentation of educational sessions within the EMEA region.

• Support initiatives for process enhancement at both regional and country levels.

• Act as a liaison between regional/country teams, Global Clinical Compliance, and global process owners.

• Facilitate the regional execution of global, local, or regional enhancements.

• Encourage the sharing of best practices across different countries and regions.

• Collaborate with Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams.

• Influence stakeholders to embrace process improvements.

• Assist with change-management activities related to new or revised processes.

⛳️ Requirements

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical, or healthcare field.

• Over 10 years of experience in clinical research or clinical operations.

• At least 4 years of experience in a GCP compliance or similar quality role is preferred.

• Exceptions may be considered for candidates possessing equivalent relevant Clinical Operations experience.

• Proficiency in PC usage is required.

• MS Office skills (Outlook, Word, Excel, PowerPoint) are essential.

• Familiarity 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 methodologies for process improvement (e.g., Lean Six Sigma) is a plus.

• Background in supporting or implementing changes to global processes.

• Experience in oncology global trials is preferred.

🏝️ Benefits

• Equal opportunity employment.

• Up to 10% travel.