Job Description Summary
The Functional Excellence Lead (FEL) leads the operational advancement of assigned Monitoring strategic capabilities across Novartis Global Clinical Operations. This role ensures innovative and effective monitoring practices are implemented consistently across regions and assures monitoring alignment with risk-based quality management (RBQM) principles and enterprise-wide transformation goals.The FEL is a strategic role with an enterprise view of monitoring processes, roles and accountabilities; the role contributes to the overall direction of the way monitoring is done at Novartis. The FEL will support efforts to optimize trial monitoring (consistency and high quality) and ensure field and central monitoring efforts are integrated and coordinated to enhance trial integrity and operational efficiency.
#LI-Hybrid
Location: London, UK or Dublin, Ireland
Multiple Positions Available
Job Description
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.
Essential Requirements:
≥ 5 years of pharmaceutical industry experience, with demonstrable experience delivering effective, innovative approaches in clinical trials
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.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Clinical Monitoring, Clinical Research, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Lifesciences, Regulatory ComplianceTop Skills
Novartis Dublin, Dublin, IRL Office
203 Merrion Rd, Dublin, Ireland, D04 NN12
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