Manager, Study Operations - North America

The Manager, Study Operations is responsible for leading and developing a team of Clinical Research Associates (CRAs)  and Clinical Trial Assistants (CTAs) to ensure the successful delivery of clinical studies in accordance with protocol requirements, ICH-GCP, applicable regulations, and company standards. This role provides operational oversight, performance coaching, resource planning, and quality management for assigned staff, while partnering closely with project teams and key stakeholders to support study execution, site performance, and high-quality monitoring activities across the clinical trial portfolio.

• Lead, coach, and develop a team of North American-based CRAs & CTAs, including onboarding, performance management, goal setting, career development, and regular feedback.
• Oversee CRA resourcing, workload allocation, and utilization across studies to ensure appropriate staffing, timely delivery, and balanced team capacity.
• Monitor the quality and consistency of site monitoring activities, visit report completion, issue escalation, follow-up actions, and adherence to monitoring plans and study timelines.
• Partner with Project Managers, and cross-functional stakeholders to support study execution, resolve operational issues, and proactively mitigate study and site risks.
• Ensure CRAs perform monitoring activities in compliance with protocol requirements, ICH-GCP, applicable FDA regulations, sponsor expectations, and internal SOPs.
• Review performance and operational metrics, identify trends or quality concerns, and implement corrective and preventive actions to improve team effectiveness and study delivery.
• Contribute to process improvement, audit and inspection readiness, and the development of monitoring standards, tools, and best practices within Study Operations.

• Bachelor’s degree in life sciences, nursing, or another relevant scientific discipline, or equivalent combination of education and experience.
• Significant experience in clinical research within a CRO, biotech, or pharmaceutical environment, including hands-on monitoring experience as a CRA.
• Previous people management or CRA line management experience, including coaching, performance management, and development of remote field-based staff.
• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial monitoring practices, with demonstrated ability to apply quality and compliance standards in study delivery.
• Experience overseeing workload planning, resource allocation, and operational performance metrics across multiple studies or programs.
• Experience supporting audit or inspection readiness, issue escalation, and continuous improvement initiatives within clinical operations is strongly preferred.

• Strong leadership, coaching, and decision-making skills, with the ability to build trust, accountability, and engagement across a remote team.
• Strong organizational and prioritization skills, with the ability to manage competing demands and drive results in a fast-paced environment.
• Analytical mindset with the ability to interpret metrics, identify risks and trends, and implement practical solutions to improve quality and operational performance.
• Proficiency with Microsoft Office and familiarity with clinical systems such as CTMS, eTMF, EDC, and related study management tools.
• Willingness and ability to travel as needed to support team oversight, co-monitoring, training, or business needs.