Job summary
This role involves leading a team responsible for clinical compliance oversight across multiple countries, ensuring adherence to Good Clinical Practice (GCP) standards and regulatory requirements. The Associate Director will drive quality and consistency in risk-based compliance activities, manage operational execution, and foster continuous improvement within the team. Collaboration with cross-functional stakeholders and alignment with global compliance strategies are key aspects of the position. Strong leadership skills and experience in clinical operations and quality compliance are essential.
Location and work setup
- Location
- Oslo
- Work setup
- On-site
Responsibilities
Lead and develop a regional team of clinical compliance professionals, providing expert guidance on GCP and regulatory standards. Oversee preparation and follow-up of inspections and audits, ensuring lessons learned are applied. Manage operational execution of compliance activities, monitor performance metrics, identify risks, and drive corrective actions. Coordinate resources and capacity planning, ensuring adequate coverage for high-risk studies. Collaborate with global and local stakeholders to align strategies and represent the compliance function in governance and cross-functional forums. Promote a culture of quality, accountability, and continuous development within the team.
Qualifications
Bachelor's degree in a scientific, medical, or healthcare discipline with at least 8 years in clinical operations and a minimum of 6 years in GCP compliance or equivalent quality roles. At least 4 years of people management experience is required. Deep knowledge of clinical trial processes, ICH-GCP guidelines, and applicable regulatory frameworks is essential. Strong organizational, communication, leadership, and analytical skills are necessary. Experience with oncology global trials is preferred. Fluency in English and the ability to work in a multicultural and matrix environment are required. Travel within the region/country is expected.