Job summary
This role involves leading clinical compliance and quality optimization efforts across multiple countries in the EMEA region. The Associate Director will analyze compliance data and trends to identify risks and opportunities for improving clinical trial processes, ensuring adherence to Good Clinical Practice and regulatory standards. Collaborating closely with global and regional teams, the position drives continuous process improvements and supports training initiatives to enhance clinical trial quality and operational excellence.
Location and work setup
- Location
- Oslo
- Work setup
- On-site
Responsibilities
Monitor and analyze compliance signals, trends, and systemic issues using audit findings, inspection outcomes, and operational data across the EMEA region. Convert these insights into actionable risk patterns and recommendations. Collaborate with Risk-Based Quality Management and process owners to propose and implement process improvements aligned with regulatory and quality standards. Support regional initiatives to improve efficiency and compliance, facilitating the implementation of best practices and training within the region. Act as a liaison between regional teams and global compliance functions, influencing stakeholders and supporting change management activities to drive adoption of enhanced processes.
Qualifications
Bachelor’s degree in a scientific, medical, or healthcare field with over 10 years in clinical research and clinical operations, including at least 4 years focused on Good Clinical Practice quality or compliance. Experience with RBQM principles, data-driven risk assessment, and process improvement methodologies such as Lean Six Sigma is preferred. Demonstrated leadership skills, excellent communication and negotiation abilities, and proficiency in computer applications are required. Familiarity with oncology global trials and certification in quality management or clinical research are advantageous. Fluency in English is essential; Norwegian language skills are not required.