Monitoring Functional Excellence Director

Job Description Summary

Leads the strategic and operational advancement of field monitoring strategic capabilities across Novartis Global Clinical Operations; embeds functional The Functional Excellence Director for site monitoring leads the strategic and operational advancement of field monitoring strategic capabilities across Novartis Global Clinical Operations. This role is pivotal in embedding functional excellence, harmonizing monitoring practices, and driving innovation across global hubs and country teams. This role supports the Monitoring Excellence Head and collaborates closely 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; the role contributes to the overall direction of the way field monitoring is done at Novartis.

The job holder 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.
#LI-Hybrid
Location: East Hanover

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:

• Define and implement excellence strategies across key monitoring roles (CRA, CPM, CRAM/MSOM, SPM, Study Lead) to both 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 & 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

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 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 us.reasonableaccommodations@novartis.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.

Salary Range

$185,500.00 - $344,500.00

Skills Desired

Agility, Budget Management, Clinical Monitoring, Clinical Trials, Decision Making Skills, Health Sciences, People Management, Regulatory Compliance, Stakeholder Engagement, Training and Development

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