Central Monitoring Head

The Role:

Welcome to the new and exciting Central Monitoring Head role - we are open for applications! The incumbent will be a: visionary, strategic leader and thrive in driving functional excellence in the monitoring of clinical trials. In alignment with recent changes of the ICH GCP, you will be building-up and overseeing state-of-the-art Central Monitoring capabilities. This opportunity is about building a new capability with new processes, growing a team, solidifying relationships in a global matrix environment, overseeing data trends by incorporating new technologies. Therefore, to be a successful applicant you will need to embrace innovation, have excellent communication skills, collaborative, agile, empathetic, empower, master change management, and have an in-depth clinical operations knowledge with a thorough understanding of trial management and field monitoring landscape.

Major accountabilities but not limited to:

• Strategy & Execution:
  • Establish and implement a Clinical Monitoring function at Novartis, including processes, tools, and governance frameworks.
  • Define and execute Clinical Monitoring strategies, leveraging data analytics and centralized oversight.
  • Develop and optimize Clinical Monitoring resourcing strategy, including hiring, onboarding, development, and retention of Clinical Monitoring Team, and perform resource management in line with Development
  • Establish and actively monitor objectives in line with GCO priorities, key metrics/KPIs and industry benchmarks.
  • Update senior leadership on CM monitoring performance, challenges, and opportunities for improvement.
  • In the long-term, ensure CM function evolves and adjusts to a remain a value-added function and to ensure compliance with latest regulations.

• Collaboration with Stakeholders:
  • Coordinate cross-functional interactions between monitoring teams and key stakeholders within Development in areas such as CDO (especially with Data Analyst team to support CM’s technologies), process and compliance, quality assurance, and regulatory affairs.
  • Act as a key connector between CM, global Risk Surveillance team, and field monitoring functions.
  • Partner with SSO Hub Heads to integrate central monitoring into existing monitoring ecosystem and adjust central and field monitoring roles accordingly.
• Leadership and Change Management:
  • Guide the organization through the transition to a CM model, driving cultural and operational change to achieve buy-in and sustained success.
  • Act as a champion for CM innovation, identifying opportunities for advancements and staying ahead of industry trends.
  • Break down silos through an enterprise mindset. Focus on delivery through collaboration and bringing people together to work towards the same purpose across the organization.

Key performance indicators:

• Successful build-up, deployment and integration of the CM function and technology platform, achieving alignment with trial monitoring workflows.
• Improved monitoring performance metrics, such as data completeness, protocol compliance, and reduction of critical findings in audits and inspections.
• Consistently high quality of monitoring deliverables, including adherence to data quality standards, risk identification, and timely issue resolution across trials.
• Achievement of monitoring milestones within defined timelines across the global portfolio, including risk-based monitoring (RBM) targets and KPIs for centralized data surveillance.
• Successful harmonization of field and CM efforts, leading to enhanced trial oversight and reduced operational variability

Your Experience:

• University degree in life science, business or operations. An Advanced degree is preferred.
• ≥ 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.
• ≥ 6 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, and Novartis standards.
• Strong capability in working in a Global/Country matrixed environment. Organizational awareness, including significant experience working cross-functionally.
• Proven track record in study operations process set-up and/or improvement(s).
• Strong technical, analytical and quantitative problem-solving skills.
• Ability to articulate the bigger picture to foster confidence and trust.
• Fluent in English

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network