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 North American clinical studies to ensure protocol, regulatory, and company compliance.
- Develop, review, and assess monitoring quality oversight plans and monitoring reports; identify trends/issues and create resolution action plans for non-compliance/data quality.
- Provide monitoring-related guidance to clinical operations teams/CROs (e.g., protocol deviations, adverse events, data quality).
- Perform risk assessments for monitoring activities; implement risk mitigation.
- Stay current on monitoring-related regulatory requirements (GCP, ICH, FDA/EMA) and advise on updates.
- Assist with SOP development/maintenance for monitoring oversight.
- Collaborate with CRO monitors; track monitoring report review metrics and compliance.
- Lead training for study teams/service providers; present oversight findings and recommendations to senior management.
- Improve processes; monitor follow-up on corrective/preventive actions; coordinate with QA for audits/inspections.
Requirements:
- BS in life science (or equivalent).
- 6+ years biotech/pharma experience, incl. 3+ years in monitoring oversight.
- 3+ years oncology experience.
- Clinical Operations experience; strong GCP/ICH/FDA/EMA knowledge; strong clinical trial process knowledge.
- Proven CRO relationship/monitoring oversight experience.
- Analytical, organizational, communication, interpersonal, and judgment skills; ability to triage/prioritize; travel up to 80%.
Total Rewards:
- Expected salary range: $168,000–$208,000.
- Benefits include medical/dental/vision, 401k, ESPP, and wellness programs.
- Conduct monitoring quality oversight visits across North American clinical studies to ensure protocol, regulatory, and company compliance.
- Develop, review, and assess monitoring quality oversight plans and monitoring reports; identify trends/issues and create resolution action plans for non-compliance/data quality.
- Provide monitoring-related guidance to clinical operations teams/CROs (e.g., protocol deviations, adverse events, data quality).
- Perform risk assessments for monitoring activities; implement risk mitigation.
- Stay current on monitoring-related regulatory requirements (GCP, ICH, FDA/EMA) and advise on updates.
- Assist with SOP development/maintenance for monitoring oversight.
- Collaborate with CRO monitors; track monitoring report review metrics and compliance.
- Lead training for study teams/service providers; present oversight findings and recommendations to senior management.
- Improve processes; monitor follow-up on corrective/preventive actions; coordinate with QA for audits/inspections.
Requirements:
- BS in life science (or equivalent).
- 6+ years biotech/pharma experience, incl. 3+ years in monitoring oversight.
- 3+ years oncology experience.
- Clinical Operations experience; strong GCP/ICH/FDA/EMA knowledge; strong clinical trial process knowledge.
- Proven CRO relationship/monitoring oversight experience.
- Analytical, organizational, communication, interpersonal, and judgment skills; ability to triage/prioritize; travel up to 80%.
Total Rewards:
- Expected salary range: $168,000–$208,000.
- Benefits include medical/dental/vision, 401k, ESPP, and wellness programs.