Monitoring Functional Excellence Lead

Job Description Summary

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 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 Monitoring 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: East Hanover
Multiple Positions Available

The ideal location for this role is East Hanover site, where hybrid working principles apply. A distant working arrangement may be considered in certain states for US associates who are not within a daily commutable distance (more than 50 miles one way). Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to East Hanover site, as determined necessary by hiring manager.

Job Description

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 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.

The salary for this position is expected to range between $145,600 and $270,400 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

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 and 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 send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$145, $270,400.00

Skills Desired

Budget Management, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Health Sciences, Lifesciences, People Management, Regulatory Compliance

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