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.

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 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 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%.