Global Monitoring Functional Excellence Director

Job Description Summary

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: London, UK or Dublin, Ireland
Role is also open in East Handover US through a separate application.

 

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

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

Skills Desired

Agility, Clinical Monitoring, Clinical Trials, Decision Making Skills, People Management, Regulatory Compliance, Stakeholder Engagement