Job Summary
A company is looking for a Senior Manager, Clinical Quality Therapeutic Area.
Key Responsibilities
- Review clinical trial protocols to ensure simplification and critical data identification
- Provide quality oversight for risk assessment and ensure patient safety and data integrity
- Develop and implement risk-based Quality Assurance plans and support clinical trial teams in quality management activities
Required Qualifications
- Doctorate degree with 2 years of quality experience, or Master's with 6 years, Bachelor's with 8 years, Associate's with 10 years, or High school diploma/GED with 12 years of quality experience
- Minimum of 2 years of experience managing people or leading teams/projects
- 5 years or more experience in Quality Management or Quality Assurance in the pharmaceutical/biotech industry
- Experience with Quality Management Systems and managing quality in electronic QMS
- Thorough understanding of Clinical R&D activities and Global Regulations
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