Monitoring Functional Excellence Lead enhancing Novartis global clinical operations through innovative practices and strategic initiatives. Overseeing adaptive monitoring and ensuring compliance with quality management principles.
Responsibilities
Leads implementation of functional strategies within assigned programs, including delivery of a data-driven adaptive monitoring approach and proportionate trial oversight.
Contributes to the development and refinement of field and central monitoring technology tools and templates and support the adoption of processes and governance frameworks for monitoring.
Support and lead cross-functional change initiatives to improve monitoring performance.
Manage strategic projects from planning through execution, ensuring stakeholder alignment.
Act as a champion for monitoring innovation, identifying opportunities for advancements and staying ahead of industry trends.
Participate in monitoring community forums and working groups to support knowledge sharing and identification of best practices.
Develop and monitor functional dashboards and KPIs and drive continuous improvement.
Drive innovation in the use of analytics, visualization, and data-driven techniques to enhance monitoring capabilities.
Monitor and report on the effectiveness of trial monitoring activities, identifying opportunities for process improvements and driving implementation of enhancements and adjustments with lessons learned.
Support the organization through the transition to a CM model, including adaptive monitoring, driving cultural and operational change to achieve buy-in and sustained success.
Requirements
≥ 5 years of pharmaceutical industry experience
Proven ability to build strong, effective partnerships with internal and external partners
Strong knowledge of current regulatory expectations related to clinical trial oversight, including monitoring
Strong project management, strategic thinking, and stakeholder engagement skills
Effective influencing, negotiation and conflict resolution skills, with enterprise mindset and demonstrated ability to drive for aligned solutions
Demonstrable experience in using data and data analyses to provide actionable insights and drive improvement
Demonstrated experience in innovation for processes, technologies and/or way of working, with a focus on sustainable and scalable solutions.
Benefits
Health, life and disability benefits
401(k) with company contribution and match
Variety of other benefits
Generous time off package including vacation, personal days, holidays and other leaves
Job title
Monitoring Functional Excellence Lead – Associate Director
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