Job summary
This role involves ensuring compliance with clinical trial regulations and company procedures at the country and site levels, focusing on risk management to guarantee patient safety, data integrity, and readiness for inspections. The manager collaborates with various stakeholders to oversee adherence to Good Clinical Practice and regulatory standards in oncology trials.
Location and work setup
- Location
- Oslo
- Work setup
- Remote
Salary
RON 243200.00–304000.00 year
Responsibilities
Serve as a primary contact for clinical compliance issues, providing expert guidance on GCP and internal standards; apply a risk-based approach to identify and manage compliance risks at country and site levels, including conducting site compliance visits; support continuous improvement by communicating trends and lessons learned; manage compliance issues and corrective actions to resolution; assist in audit and inspection preparations and execution.
Qualifications
Bachelor's degree or higher in scientific, medical, or healthcare discipline; at least 5 years in clinical operations and 4 years in GCP compliance or related quality roles; preferred experience in global oncology trials; strong understanding of clinical trial processes and regulatory guidelines; excellent analytical, communication, organizational, and multitasking abilities; fluent in English; ability to work independently and in multicultural environments; willingness to travel up to 20-30%.