Senior Manager, Monitoring Quality Oversight
IDEAYA Biosciences
August 18, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
What you’ll do:
- Conduct monitoring quality oversight visits across all North America clinical studies to ensure compliance with protocols, regulatory guidelines, and company policies.
- Develop and implement monitoring quality oversight plans; review monitoring plans/reports and create action plans for non-compliance/data quality issues.
- Provide guidance on monitoring-related matters (e.g., protocol deviations, adverse events, data quality assessments).
- Perform risk assessments for monitoring activities and create mitigation plans.
- Stay current on regulatory requirements and best practices; support implementation.
- Assist with Standard Operating Procedures (SOPs) for monitoring oversight; collaborate with CRO monitors.
- Track monitoring report review metrics; lead training; present findings/recommendations to senior management.
- Monitor adherence to corrective/preventive action plans and coordinate with Quality Assurance for audits/inspections.
Requirements:
- Bachelor’s degree in life science (or equivalent).
- 6+ years biotech/pharma experience; 3+ years specifically in monitoring oversight.
- 3+ years oncology experience.
- Clinical Operations experience; strong GCP, ICH, and FDA/EMA guideline knowledge; strong understanding of clinical trial processes.
- Proven CRO relationship management and monitoring oversight experience.
- Excellent analytical, communication, organizational, and judgment skills; ability to travel up to 80%.
- Proficiency with MS Office; clinical trial/data management systems; Smartsheet a plus.
Total rewards (salary/benefits as stated):
- Expected salary range: $168,000–$208,000.
- Medical/dental/vision (100% employee; 90% dependents), 401k, ESPP, wellness programs.
- Conduct monitoring quality oversight visits across all North America clinical studies to ensure compliance with protocols, regulatory guidelines, and company policies.
- Develop and implement monitoring quality oversight plans; review monitoring plans/reports and create action plans for non-compliance/data quality issues.
- Provide guidance on monitoring-related matters (e.g., protocol deviations, adverse events, data quality assessments).
- Perform risk assessments for monitoring activities and create mitigation plans.
- Stay current on regulatory requirements and best practices; support implementation.
- Assist with Standard Operating Procedures (SOPs) for monitoring oversight; collaborate with CRO monitors.
- Track monitoring report review metrics; lead training; present findings/recommendations to senior management.
- Monitor adherence to corrective/preventive action plans and coordinate with Quality Assurance for audits/inspections.
Requirements:
- Bachelor’s degree in life science (or equivalent).
- 6+ years biotech/pharma experience; 3+ years specifically in monitoring oversight.
- 3+ years oncology experience.
- Clinical Operations experience; strong GCP, ICH, and FDA/EMA guideline knowledge; strong understanding of clinical trial processes.
- Proven CRO relationship management and monitoring oversight experience.
- Excellent analytical, communication, organizational, and judgment skills; ability to travel up to 80%.
- Proficiency with MS Office; clinical trial/data management systems; Smartsheet a plus.
Total rewards (salary/benefits as stated):
- Expected salary range: $168,000–$208,000.
- Medical/dental/vision (100% employee; 90% dependents), 401k, ESPP, wellness programs.