Senior Manager, Monitoring Quality Oversight

Job Summary About IDEAYA Biosciences: IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small‑molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first‑in‑class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody‑drug conjugates, or ADCs, for molecularly defined solid tumor indications.

Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person  are inquisitive, ask deep questions, and are data‑driven innovators who like to collaborate and use teamwork to move science forward.

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Location:

South San Francisco, CA. or San Diego, CA.

Position Summary:

IDEAYA is seeking a talented, experienced, and highly motivated Monitoring Quality Oversight Manger in Clinical Operations with a passion for new cancer therapy development. This role will be responsible for monitoring quality oversight across multiple studies, thus supporting the Clinical Operations team in the operational execution of IDEAYA’s clinical trials. As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data quality and compliance within clinical operations.

This role involves a proactive approach to monitoring oversight, including collaboration with CROs and internal teams to identify and mitigate risks, streamline processes, and implement best practices. The successful candidate will have a strong background in clinical operations, excellent analytical skills, and the ability to provide strategic guidance to ensure the integrity of clinical trial data. As a member of our dynamic adhering group, you will help to grow IDEAYA’s pipeline and you will play a pivotal role in ensuring the quality and integrity of clinical trial data through effective oversight of the CRO monitors.

This position is based in our South San Francisco headquarter offices or San Diego office and required to be onsite four days per week per our company policy. Reporting to:
Senior Director, Clinical Operations

• Conduct monitoring quality oversight visits across all clinical studies in North America to ensure compliance with study protocols, regulatory guidelines, and company policies.
• Generate and implement comprehensive monitoring quality oversight plans tailored to specific studies, aligning objectives with organizational goals and project timelines.
• Review and assess monitoring plans for each study, ensuring they are robust, comprehensive, and reflective of best practices in clinical monitoring.
• Evaluate monitoring reports in preparation for oversight visits, identify potential issues or trends and developing appropriate action plans for resolution to address any non‑compliance or data quality concerns.
• Provide expert guidance and support to clinical operations study teams and service providers on monitoring‑related matters, including but not limited to protocol deviations, adverse events, and data quality assessments.
• Conduct risk assessments regarding monitoring activities and develop risk mitigation plans to uphold the quality and integrity of clinical trial data.
• Stay updated on regulatory requirements, guidelines, and industry best practices related to monitoring oversight, ensuring their effective implementation within the…