Novartis
Monitoring Functional Excellence Lead (Associate Director)
Novartis, East Hanover, New Jersey, us, 07936
Monitoring Functional Excellence Lead (Associate Director)
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About The Role The Monitoring 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 aligns monitoring with risk-based quality management (RBQM) principles and enterprise-wide transformation goals. The FEL supports efforts to optimize trial monitoring and integrates field and central monitoring to enhance trial integrity and operational efficiency.
Location: East Hanover – hybrid working principles apply. Remote work may be considered for U.S. associates not within a daily commutable distance (more than 50 miles one way). Remote workers are responsible for home office expenses and periodic travel/lodging to East Hanover site as determined necessary by the hiring manager.
Key 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 supports the adoption of processes and governance frameworks for monitoring.
Supports and leads cross-functional change initiatives to improve monitoring performance.
Manages strategic projects from planning through execution, ensuring stakeholder alignment.
Acts as a champion for monitoring innovation, identifying opportunities for advancements and staying ahead of industry trends.
Participates in monitoring community forums and working groups to support knowledge sharing and identification of best practices.
Develops and monitors functional dashboards and KPIs and drives continuous improvement.
Drives innovation in the use of analytics, visualization, and data-driven techniques to enhance monitoring capabilities.
Monitors and reports on the effectiveness of trial monitoring activities, identifying opportunities for process improvements and driving implementation of enhancements and adjustments with lessons learned.
Supports 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.
Salary range: $145,600 – $270,400 per year. The final salary offered is determined based on relevant skills and experience and upon joining Novartis will be reviewed periodically.
Benefits and Rewards: Comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and generous time off. Eligible employees receive a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please email
[email protected]
or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
#J-18808-Ljbffr
About The Role The Monitoring 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 aligns monitoring with risk-based quality management (RBQM) principles and enterprise-wide transformation goals. The FEL supports efforts to optimize trial monitoring and integrates field and central monitoring to enhance trial integrity and operational efficiency.
Location: East Hanover – hybrid working principles apply. Remote work may be considered for U.S. associates not within a daily commutable distance (more than 50 miles one way). Remote workers are responsible for home office expenses and periodic travel/lodging to East Hanover site as determined necessary by the hiring manager.
Key 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 supports the adoption of processes and governance frameworks for monitoring.
Supports and leads cross-functional change initiatives to improve monitoring performance.
Manages strategic projects from planning through execution, ensuring stakeholder alignment.
Acts as a champion for monitoring innovation, identifying opportunities for advancements and staying ahead of industry trends.
Participates in monitoring community forums and working groups to support knowledge sharing and identification of best practices.
Develops and monitors functional dashboards and KPIs and drives continuous improvement.
Drives innovation in the use of analytics, visualization, and data-driven techniques to enhance monitoring capabilities.
Monitors and reports on the effectiveness of trial monitoring activities, identifying opportunities for process improvements and driving implementation of enhancements and adjustments with lessons learned.
Supports 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.
Salary range: $145,600 – $270,400 per year. The final salary offered is determined based on relevant skills and experience and upon joining Novartis will be reviewed periodically.
Benefits and Rewards: Comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and generous time off. Eligible employees receive a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please email
[email protected]
or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
#J-18808-Ljbffr