Senior Manager, Monitoring Quality Oversight

About the role

IDEAYA is seeking a talented, experienced, and highly motivated Monitoring Quality Oversight Manager 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.

Responsibilities

• 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 develop 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 organization and advising on necessary changes.
• Aid in the development and maintenance of Standard Operating Procedures (SOPs) related to monitoring oversight, ensuring adherence and compliance across all studies, and updating them as necessary.
• Collaborate with CRO monitors to ensure effective management of monitoring activities while adhering to quality standards and fostering a strong, transparent partnership.
• Maintain tracking of clinical operations monitoring report review metrics and compliance to ensure continuous improvement in monitoring oversight.
• Lead training and development initiatives for study teams and service providers to ensure a clear understanding of monitoring practices, responsibilities, and expectations.
• Prepare and present findings from monitoring oversight activities to senior management, providing insights and recommendations for enhancing the overall quality assurance framework.
• Identify potential areas for process improvement within the monitoring oversight function, implementing changes that promote efficiency, effectiveness, and compliance.
• Monitor adherence to action plans developed during oversight visits and ensure proper follow-up on corrective and preventive actions.
• Cook up coordination with the quality assurance team to support audits and inspections, ensuring that all documentation and processes meet required standards.

Requirements

• Bachelor’s Degree in life science or equivalent combination of education, training, and relevant experience
• Minimum 6 years of relevant experience in biotech or pharmaceutical industry, of which a minimum of 3 years of focusing on monitoring oversight within a biotech or pharmaceutical setting.
• At least 3 years of experience in oncology.
• Strong understanding of clinical trial processes.
• Proven experience in managing CRO relationships and overseeing monitoring activities.
• Self-motivated, with initiative and able to take ownership of, and follow through with, specific tasks.
• Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships.
• Exceptional analytical skills, with the ability to assess data and trends effectively.
• Ability to exercise good judgment and make decisions that are appropriate for IDEAYA.
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
• Excellent communication and interpersonal skills, with the ability to provide clear guidance and support to cross-functional teams.
• Analyze and triage problems, prioritize accordingly, and propose solutions.
• Strive for continuous improvement and embrace innovative ideas in daily work.
• Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines.
• Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Adobe Acrobat), clinical trial management systems, data management tools and experience with Smartsheet is a plus.
• Ability to travel up to 80%.