Senior Clinical Operations Manager

Job description

**This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Clinical Operations Manager based in United States.** The Senior Clinical Operations Manager will lead and develop clinical operations teams, ensuring the successful delivery of high-quality clinical trials across a diverse portfolio of studies. This role combines people leadership, strategic oversight, resource planning, and operational excellence in a dynamic clinical research environment. You will coach and mentor Clinical Trial Managers, Clinical Research Associates, and other clinical operations professionals while fostering accountability and continuous improvement. Working closely with project management, finance, sponsors, and cross-functional teams, you will ensure studies meet quality, regulatory, timeline, and budget expectations. You will oversee performance indicators, proactively manage operational risks, and strengthen quality governance across clinical trial activities. The position also offers the opportunity to drive digital transformation by integrating technology, automation, and AI-powered tools into clinical operations. This is an excellent opportunity for an experienced clinical research leader seeking to shape operational strategy, develop high-performing teams, and improve clinical trial delivery. ### Accountabilities - Clinical operations leadership: Oversee clinical monitoring and trial management activities across assigned teams, ensuring high-quality deliverables, sponsor satisfaction, and compliance with timelines, budgets, standard operating procedures, Good Clinical Practice (GCP), and study-specific requirements. - Team management and development: Lead, coach, and evaluate Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and other clinical operations professionals. Support recruitment, onboarding, training, retention, succession planning, and professional development while ensuring individual performance aligns with departmental objectives. - Resource and capacity planning: Coordinate staffing and resource allocation across studies, maintain balanced workloads, anticipate capacity requirements, and ensure teams have the expertise and support needed to deliver clinical projects effectively. - Performance and financial oversight: Monitor operational KPIs, performance trends, productivity, and resource utilization. Ensure study activities remain within approved budgets and collaborate with Project Management and Finance to identify financial or operational risks and implement mitigation strategies. - Quality assurance and compliance: Conduct or oversee Quality Assessment Visits (QAVs), review site visit reports, identify quality concerns, and ensure appropriate corrective and preventive actions are implemented. Promote consistent adherence to regulatory requirements, internal procedures, and quality standards. - Risk management and escalation: Act as a key escalation point for clinical operations teams, sponsors, and stakeholders. Address complex operational challenges, support proactive problem-solving, and ensure timely resolution of issues affecting study quality or delivery. - Training and process improvement: Contribute to the development and implementation of training programs, ensuring consistent adoption of clinical operations procedures, tools, and systems. Identify opportunities to streamline workflows and improve operational effectiveness. - Innovation and digital transformation: Champion continuous improvement through technology, automation, and AI-enabled solutions. Explore practical applications of digital tools to increase CTM productivity, strengthen oversight, improve decision-making, and enhance clinical trial delivery. - Cross-functional collaboration: Build strong working relationships with clinical project teams and other departments to align priorities, share expertise, manage change, and support the organization's broader operational objectives. ## Requirements - Education: Bachelor's degree in clinical research or a related field.<