Leader of Clinical Monitoring (Digital & AI Transformation Focus)

📋 Description

• • Lead the global strategic transformation of clinical monitoring operations by transitioning from traditional models to agentic, AI-powered monitoring workflows powered by Medable’s digital platform.
• • Design and implement a scalable, global clinical monitoring strategy aligned with 1:1:1 goals, regulatory requirements (GCP, GxP), and long-term ROI objectives.
• • Build and lead a high-performing global team of Clinical Research Associates (CRAs) trained in digital literacy, data interpretation, and collaboration with AI agents.
• • Redefine CRA roles, responsibilities, and operating frameworks to integrate autonomous AI agents with human-in-the-loop oversight for optimized monitoring outcomes.
• • Deploy and manage production-grade AI agents to deliver end-to-end clinical monitoring services, ensuring ethical, compliant, and trustworthy AI use in clinical operations.
• • Establish and maintain a quality framework with standardized global SOPs that accommodate regional regulatory differences while ensuring audit readiness and regulatory compliance.
• • Implement AI-powered quality surveillance systems to proactively identify operational risks, mitigate non-compliance, and drive continuous improvement through data-driven insights.
• • Develop and monitor KPIs and executive dashboards tracking monitoring efficiency, quality metrics, cycle times, resource allocation, and gross margin performance.
• • Optimize monitoring resource allocation and productivity using data-driven analytics to meet revenue, SLA, and margin targets.
• • Serve as the primary liaison between clinical operations and cross-functional teams including Data Management, Biostatistics, IT, and Clinical Operations to align digital transformation initiatives.
• • Represent Medable in industry forums on AI in clinical trials, promoting innovation and adoption of digital monitoring standards among sponsors, CROs, and sites.
• • Collaborate with executive leadership to communicate clinical operations performance, innovation progress, and strategic roadmaps for AI-enabled monitoring.
• • Champion change management initiatives across global, matrixed organizations to drive adoption of new monitoring models and ensure organizational buy-in.
• • Translate vision into actionable execution by aligning digital transformation initiatives with business outcomes, including revenue growth and operational scalability.
• • Publish evidence-based success criteria, iterative learnings, and best practices for ethical AI use in clinical trial monitoring to reinforce organizational credibility.
• • Foster a culture of innovation, accountability, and continuous learning within the global clinical monitoring team, emphasizing adaptability and digital fluency.
• • Ensure all AI-driven monitoring activities remain fully compliant with global regulatory guidelines and support regulatory inspections with documented evidence and audit trails.
• • Drive the creation and maintenance of a long-term roadmap for agentic clinical monitoring operations that scales with organizational growth and evolving regulatory landscapes.