Overview
Monitoring Functional Excellence Director: Leads the strategic and operational advancement of field monitoring capabilities across Novartis Global Clinical Operations. Embeds functional excellence, harmonizes monitoring practices, and drives innovation across global hubs and country teams. 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 for site monitoring is a strategic leader with an enterprise view of monitoring processes, roles and accountabilities; the role 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 consistent with global regulatory authority 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 efforts are integrated and coordinated 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 in certain states for US associates who are not within daily commuting 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 by the hiring manager.
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 IQRMP process.
* Lead capability development for field-based staff, ensuring the function is equipped to operate in an agile, RBQM model.
* Lead transformation programs involving multiple geographies and therapeutic areas to strengthen and modernize trial monitoring.
* Act as a champion for innovation, 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 of 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 previous experience in global strategy and/or clinical research, in a Pharmaceutical Industry, CROs, or regulatory agency.
* Strong leadership skills in a global setting and proven ability to develop high performing teams and diverse profiles.
* Strong understanding of clinical trials and evolving regulatory expectations for trial monitoring.
* Experience in building a new capability or transforming significantly an existing capability.
* Proven ability to build effective partnerships with internal and external partners.
* Effective influencing, negotiation and conflict resolution skills, with enterprise mindset and demonstrated ability to drive for aligned solutions.
Desirable Requirements
* Aptitude for data analytics and critical thinking skills.
* Demonstrated leadership in innovation for processes, technologies and way of working, with a 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. 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 & Accessibility
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.
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If 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 novartis.support@example.com 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