Executive Director, Monitoring Excellence Head

Job Description Summary

Onsite
#LI-Onsite
East Hanover, New Jersey

About the role:
We have an exciting opportunity as an Executive Director, Monitoring Excellence Head. In this role, you will be leading the strategic vision, drive end-to-end functional excellence in clinical trial monitoring, foster collaboration within the organization across global, hubs and country teams with the business across programs and trials for clinical trial teams-roles interacting with monitoring roles (CRAs, Central Monitors, CPMs).

 

Job Description

Your Key Responsibilities:

• Establish and implement a Monitoring Excellence function at Novartis, which includes two organizational pillars: central monitoring and field monitoring excellence and ensure the alignment between two pillars.
• Establish and actively monitor central monitoring objectives in line with Global Clinical Operations. priorities, key metrics/KPIs and industry benchmarks. Oversees and reports on monitoring performance, challenges, and opportunities for improvement for senior leadership.
• In the long-term, ensure central monitoring function evolves and adjusts to a remain a value-added function and to ensure compliance with latest regulations.
• Coordinate cross-functional interactions between monitoring teams and key stakeholders within Development in areas such as Clinical Data Operations (especially with Data Analyst team to support Central Monitoring’s technologies), process and compliance, quality assurance, and regulatory affairs.
• Serve as the central point of contact for monitoring-related queries for HA sponsor’s inspections and group audits, coordinating preparation activities, providing expert insights, facilitating responses and follow-up actions.
• Set-up a functional center of excellence in field monitoring in line with best-in-industry practices. Ensure that monitoring organization structure and capabilities are aligned to effectively address current needs (internals/externals).
• In partnership with Site and Study Operations Hubs and Country Leadership, establish and implement global strategies to increase and sustain high performance and quality in monitoring activities. Develop and implement frameworks for monitoring performance metrics, provide strategic leadership to field monitoring teams, establishing monitoring best practice and standards, ensuring consistency across Hubs and countries.
• Establish solid collaboration with Clinical Data Operations and Clinical Development functions to consider interdependencies with other key activities relating to Data Quality and RBQM and synergized actions to drive robust operational performance within Development.
• Guide the organization through the transition to a Central Monitoring model, driving cultural and operational change to achieve buy-in and sustained success.
• Oversee the deployment of technology for Central Monitoring, in collaboration with Clinical Data Operations. 
   

Video Link  https://www.youtube.com/watch?v=ggbnzRY9z8w 
 

The ideal location for this role is the East Hanover site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel.

Role Requirements:
Essential Requirements:

• Bachelor of Science degree in life science, business or operations with 10+ years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs. Strong clinical and budgeting/finance experience with excellent understanding of clinical trial development and risk management processes and the management of clinical trials. Specific central monitoring / monitoring experience preferred.
• 8 years of recent experience in people management and/or team leadership. Strong leadership and people management skills in global setting and proven ability to develop high performing teams and diverse profiles including manager of manager experience.
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards.
• Strong capability in working in a Global/Country matrixed environment. Organizational awareness, including s