Senior Manager Quality Monitoring Oversight

Senior Manager, Monitoring Quality Oversight

The Senior Manager, Monitoring Quality Oversight is responsible for leading monitoring quality oversight across multiple clinical studies, supporting the Clinical Operations team in the effective execution of clinical trials. This role oversees Contract Research Organization (CRO) monitoring activities to ensure the highest standards of data quality, regulatory compliance, and operational excellence. The position requires a proactive, strategic approach to monitoring oversight, close collaboration with CROs and internal teams, and a strong background in clinical operations, particularly within oncology and pharmaceutical environments.

• Conduct monitoring quality oversight visits across clinical studies in North America to verify compliance with study protocols, regulatory guidelines, Good Clinical Practice (GCP), and internal policies.
• Generate and implement comprehensive monitoring quality oversight plans tailored to individual studies, ensuring alignment with organizational goals and project timelines.
• Review and assess monitoring plans for each study to confirm they are robust, comprehensive, and consistent with best practices in clinical monitoring.
• Evaluate monitoring reports in preparation for oversight visits, identify potential issues or trends, and develop appropriate action plans to address non-compliance or data quality concerns.
• Provide expert guidance and support to clinical operations study teams and service providers on monitoring-related matters, including protocol deviations, adverse events, and data quality assessments.
• Conduct risk assessments related to monitoring activities and develop risk mitigation plans that protect the quality and integrity of clinical trial data.
• Stay current with regulatory requirements, guidelines, and industry best practices related to monitoring oversight, and ensure their effective implementation across studies.
• Assist in the development, maintenance, and continuous improvement of Standard Operating Procedures (SOPs) related to monitoring oversight, ensuring adherence and consistency.
• Collaborate closely with CRO monitors to manage monitoring activities effectively, maintain high quality standards, and foster a transparent, productive partnership.
• Maintain tracking of clinical operations monitoring report review metrics and compliance, using these data to drive continuous improvement in monitoring oversight.
• Lead training and development initiatives for study teams and service providers to clarify monitoring practices, responsibilities, and expectations.
• Prepare and present findings from monitoring oversight activities to Senior leadership, offering insights and recommendations to strengthen the overall quality assurance framework.
• Identify and implement process improvements within the monitoring oversight function to enhance efficiency, effectiveness, and compliance.
• Monitor adherence to action plans developed during oversight visits and ensure timely follow-up on corrective and preventive actions.
• Coordinate with the quality assurance team to support audits and inspections, ensuring documentation, processes, and monitoring activities meet required standards.
• Contribute to the growth of the clinical development pipeline by ensuring the quality and integrity of clinical trial data through rigorous oversight of CRO monitors.

• Strong background in clinical operations within the pharmaceutical or biotechnology industry.
• Proven experience overseeing CRO monitoring activities in clinical trials.
• In-depth knowledge of Good Clinical Practice (GCP), study protocols, and regulatory guidelines relevant to clinical research.
• Demonstrated expertise in monitoring quality oversight and data quality assurance.
• Strong analytical skills with the ability to identify trends, assess risks, and develop effective mitigation strategies.
• Experience working on oncology clinical studies.
• Ability to generate, review, and refine monitoring plans and monitoring quality oversight plans.
• Proven capability to interpret monitoring reports and translate findings into actionable improvement plans.
• Strong communication skills,…