Hybrid Monitoring Functional Excellence Lead – Associate Director

Posted 2 months ago

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About the role

  • 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

Job type

Experience level

Senior

Salary

$145,600 - $270,400 per year

Degree requirement

Bachelor's Degree

Location requirements

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