Job
Description
Strategy & Execution: Establish and implement a Clinical Monitoring function at Novartis, including processes, tools, and governance frameworks. Define and execute Clinical Monitoring strategies, leveraging data analytics and centralized oversight. Develop and optimize Clinical Monitoring resourcing strategy, including hiring, onboarding, development, and retention of Clinical Monitoring Team, and perform resource management in line with Development Establish and actively monitor objectives in line with GCO priorities, key metrics/KPIs and industry benchmarks. Update senior leadership on CM monitoring performance, challenges, and opportunities for improvement. In the long-term, ensure CM function evolves and adjusts to a remain a value-added function and to ensure compliance with latest regulations. Collaboration with Stakeholders: Coordinate cross-functional interactions between monitoring teams and key stakeholders within Development in areas such as CDO (especially with Data Analyst team to support CMs technologies), process and compliance, quality assurance, and regulatory affairs. Act as a key connector between CM, global Risk Surveillance team, and field monitoring functions. Partner with SSO Hub Heads to integrate central monitoring into existing monitoring ecosystem and adjust central and field monitoring roles accordingly. Leadership and Change Management: Guide the organization through the transition to a CM model, driving cultural and operational change to achieve buy-in and sustained success. Act as a champion for CM innovation, identifying opportunities for advancements and staying ahead of industry trends. Break down silos through an enterprise mindset. Focus on delivery through collaboration and bringing people together to work towards the same purpose across the organization. Key performance indicators: Successful build-up, deployment and integration of the CM function and technology platform, achieving alignment with trial monitoring workflows. Improved monitoring performance metrics, such as data completeness, protocol compliance, and reduction of critical findings in audits and inspections. Consistently high quality of monitoring deliverables, including adherence to data quality standards, risk identification, and timely issue resolution across trials. Achievement of monitoring milestones within defined timelines across the global portfolio, including risk-based monitoring (RBM) targets and KPIs for centralized data surveillance. Successful harmonization of field and CM efforts, leading to enhanced trial oversight and reduced operational variability Role & responsibilities Preferred candidate profile Perks and benefits
