Clinical Operations Compliance Director

Job Summary

Supporting oncology clinical research activities, the full-time Associate Clinical Operations Compliance Director will manage risk and issue processes, ensure compliance with regulations, and collaborate with cross-functional teams in a remote setting.

Key responsibilities

• Support risk and issue management processes for compliant study execution
• Drive inspection readiness and oversee monitoring quality and CRO performance
• Collaborate with Quality Assurance and other functional teams to address operational issues and ensure compliance

Required qualifications

• Bachelor's degree in a related discipline with a minimum of 11 years of experience, or equivalent education and experience
• Experience in the biotech or pharmaceutical industry is required
• Strong knowledge of biopharmaceutical industry regulations and best practices
• Ability to work independently and collaboratively in a fast-paced environment
• Excellent analytical and strategic thinking skills