Lead Central Monitor, Associate Director
Job ID REQ-10047948
Apr 13, 2025
Summary
The Lead Central Monitor supports the Central Monitoring Head in enhancing clinical trial monitoring by establishing and delivering a state-of-the-art Central Monitoring (CM) capability at Novartis in Global Clinical Operations (GCO).
The Lead CM manages a team of Central Monitors, develops monitoring strategies, and ensures the CM platform aligns with strategic needs, indications, program, and study risks, in accordance with the IQRMP, to ensure proper trial data surveillance, quality, and integrity.
About the Role
Major accountabilities include:
* Establish and implement a CM function at Novartis, including processes, tools, and governance frameworks supporting RBQM.
* Manage and mentor a team of CMs, fostering development and maintaining high performance.
* Partner with the CM Head to define and refine the CM strategy and improve RBM processes organization-wide.
* Analyze CM dashboards and data visualization tools to identify risks and ensure accurate root cause analysis and mitigation.
* Contribute to protocol development and study setup to identify risks and align with RBQM.
* Ensure effective trial data surveillance to uphold data quality and integrity.
* Evaluate, adopt, and improve CM tools and technologies, ensuring seamless integration into workflows.
* Drive innovation using analytics, visualization, and data-driven techniques for enhanced risk monitoring.
Education & Experience
* University degree in life sciences, business, or operations; advanced degree preferred.
* ≥ 7 years of recent pharmaceutical industry experience, including clinical research and trial management.
* Hands-on experience with Key Risk Indicators (KRIs), centralized monitoring, and QTLs is strongly preferred.
* Experience with RBQM and adaptive monitoring frameworks.
* ≥ 3 years in people management or team leadership, with a proven track record in a global setting.
* ≥ 5 years in monitoring (central and site), clinical data analytics, or related activities.
* Knowledge of clinical trial planning, execution, risks, and risk management processes.
* Experience developing quality control documentation for remote/central monitoring.
* Understanding of international standards (GCP/ICH), health authorities, and Novartis standards.
* Strong analytical skills to interpret complex clinical and operational data.
* Ability to assess study protocols and operational risks effectively.
Why Novartis
Join us in transforming patient lives through innovation and collaboration. Learn more about our culture: https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion
Novartis is dedicated to fostering an inclusive and diverse work environment that reflects the communities we serve.
Join our Talent Community: Stay connected and be informed about future opportunities: https://talentnetwork.novartis.com/network
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