Novartis
Monitoring Functional Excellence Director – Novartis
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Monitoring Functional Excellence Director
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Novartis . Summary: Leads the strategic and operational advancement of field monitoring strategic capabilities across Novartis Global Clinical Operations. The Functional Excellence Director for site monitoring embeds functional excellence, harmonizes monitoring practices, and drives innovation across global hubs and country teams. This role supports the Monitoring Excellence Head and collaborates with the Central Monitoring Head to ensure alignment with RBQM principles and enterprise-wide transformation goals. The Functional Excellence Director is a strategic leader with an enterprise view of monitoring processes, roles and accountabilities; contributes to the overall direction of the way field monitoring is done at Novartis. The role embeds innovation in on-site monitoring, develops harmonized process standards aligned with global regulatory expectations, and implements tools and metrics to assess the operational health of monitoring activities. The leader will optimize field monitoring (consistency and high quality) and ensure field and central monitoring are integrated to enhance trial integrity and operational efficiency. Location : East Hanover. The ideal location is East Hanover with hybrid working principles. A distant working arrangement may be considered for US associates not within a daily commutable distance (more than 50 miles one way). Distant workers cover home office expenses and travel/lodging as determined by the hiring manager. Why Novartis:
Helping people with disease and their families requires a community of smart, passionate people. This role participates in a culture of collaboration, support and innovation. Key responsibilities : Define and implement excellence strategies across key monitoring roles (CRA, CPM, CRAM/MSOM, SPM, Study Lead) to streamline and strengthen monitoring at Novartis. Embed risk-based approaches in all monitoring practices and ensure a clear connection between field monitoring activities and the RBQM process. Lead capability development for field-based staff to operate in an agile, RBQM model. Lead transformation programs across geographies and therapeutic areas to strengthen and modernize trial monitoring. Champion innovation by identifying opportunities for advancements and staying ahead of industry trends. Serve as a strategic advisor to senior leadership on field excellence and capability gaps. Promote the implementation and champion digital tools and advanced analytics to strengthen field monitoring processes. Partner with Compliance to identify and implement process improvements across field monitoring. Essential requirements : ≥ 8 years of recent pharmaceutical industry experience, with global strategy and/or clinical research exposure in pharma, CROs, or regulatory agencies. Strong global leadership skills and proven ability to develop high-performing, diverse teams. Strong understanding of clinical trials and evolving regulatory expectations for trial monitoring. Experience in building a new capability or transforming a significant existing capability. Proven ability to build effective partnerships with internal and external stakeholders. Effective influencing, negotiation and conflict resolution skills with an enterprise mindset and ability to drive aligned solutions. Desirable requirements : Aptitude for data analytics and critical thinking. Demonstrated leadership in process and technology innovation with focus on sustainable and scalable solutions. Digital savviness. Compensation and benefits : The salary for this position is expected to range between $185,500 and $344,500 per year. Final salary is determined based on relevant skills and experience and will be reviewed periodically. Eligible US-based employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and other benefits. A generous time off package is provided including vacation, personal days, holidays and other leaves. Performance-based incentive eligibility and potential annual equity awards may apply. EEO statements and accommodations : 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. We are committed to providing reasonable accommodations to individuals with disabilities; if you need accommodation during the application process or to perform essential job functions, please email us and include your contact information and the job requisition number. To learn more about culture, rewards and benefits: contact the Novartis careers team.
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Join to apply for the
Monitoring Functional Excellence Director
role at
Novartis . Summary: Leads the strategic and operational advancement of field monitoring strategic capabilities across Novartis Global Clinical Operations. The Functional Excellence Director for site monitoring embeds functional excellence, harmonizes monitoring practices, and drives innovation across global hubs and country teams. This role supports the Monitoring Excellence Head and collaborates with the Central Monitoring Head to ensure alignment with RBQM principles and enterprise-wide transformation goals. The Functional Excellence Director is a strategic leader with an enterprise view of monitoring processes, roles and accountabilities; contributes to the overall direction of the way field monitoring is done at Novartis. The role embeds innovation in on-site monitoring, develops harmonized process standards aligned with global regulatory expectations, and implements tools and metrics to assess the operational health of monitoring activities. The leader will optimize field monitoring (consistency and high quality) and ensure field and central monitoring are integrated to enhance trial integrity and operational efficiency. Location : East Hanover. The ideal location is East Hanover with hybrid working principles. A distant working arrangement may be considered for US associates not within a daily commutable distance (more than 50 miles one way). Distant workers cover home office expenses and travel/lodging as determined by the hiring manager. Why Novartis:
Helping people with disease and their families requires a community of smart, passionate people. This role participates in a culture of collaboration, support and innovation. Key responsibilities : Define and implement excellence strategies across key monitoring roles (CRA, CPM, CRAM/MSOM, SPM, Study Lead) to streamline and strengthen monitoring at Novartis. Embed risk-based approaches in all monitoring practices and ensure a clear connection between field monitoring activities and the RBQM process. Lead capability development for field-based staff to operate in an agile, RBQM model. Lead transformation programs across geographies and therapeutic areas to strengthen and modernize trial monitoring. Champion innovation by identifying opportunities for advancements and staying ahead of industry trends. Serve as a strategic advisor to senior leadership on field excellence and capability gaps. Promote the implementation and champion digital tools and advanced analytics to strengthen field monitoring processes. Partner with Compliance to identify and implement process improvements across field monitoring. Essential requirements : ≥ 8 years of recent pharmaceutical industry experience, with global strategy and/or clinical research exposure in pharma, CROs, or regulatory agencies. Strong global leadership skills and proven ability to develop high-performing, diverse teams. Strong understanding of clinical trials and evolving regulatory expectations for trial monitoring. Experience in building a new capability or transforming a significant existing capability. Proven ability to build effective partnerships with internal and external stakeholders. Effective influencing, negotiation and conflict resolution skills with an enterprise mindset and ability to drive aligned solutions. Desirable requirements : Aptitude for data analytics and critical thinking. Demonstrated leadership in process and technology innovation with focus on sustainable and scalable solutions. Digital savviness. Compensation and benefits : The salary for this position is expected to range between $185,500 and $344,500 per year. Final salary is determined based on relevant skills and experience and will be reviewed periodically. Eligible US-based employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and other benefits. A generous time off package is provided including vacation, personal days, holidays and other leaves. Performance-based incentive eligibility and potential annual equity awards may apply. EEO statements and accommodations : 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. We are committed to providing reasonable accommodations to individuals with disabilities; if you need accommodation during the application process or to perform essential job functions, please email us and include your contact information and the job requisition number. To learn more about culture, rewards and benefits: contact the Novartis careers team.
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