Key responsibilities:

• Responsible for all SSU activities for medium to highly complex high-priority studies, including independent decision-making and strategy development.
• Develops SSU strategies and aligns plans with trial OEP to ensure timely milestones and successful execution across countries and sites.
• Oversees trial-specific setup of SSU systems (e.g., eTMF, CTMS, site contracting tools, vendor management, ICF templates, translations, etc.).
• Ensures readiness of global trial documents, activates protocol amendments, and oversees country implementation for HA and Ethics Committee submissions.
• Guides Vendor Program Manager (VPM) and collaborates with GCS to ensure vendor activation and clinical supply readiness for site activation timelines.
• Leads SSU Teams, coaches country SSU Managers, and ensures effective execution and adherence to process standards across global and country levels.
• Provides oversight, drives risk management, ensures TMF inspection readiness, and maintains compliance with Novartis standards and regulations.
• Drives training, compliance, SOP/WP reviews, and contributes as SME for initiatives, potentially acting as SSU Director deputy and mentoring team members.

Essential requirements:

• Advanced degree preferred or Bachelor’s degree with equivalent experience in scientific or health disciplines.
• Fluent English, oral and written.
• Minimum 6 years in project management roles overseeing and/or monitoring clinical trials.
• At least 3 years of experience contributing to planning, execution, reporting, and publishing clinical trials in global or matrixed environments.
• Proven ability to engage and lead multidisciplinary teams across diverse functions and backgrounds in complex matrix organizations.
• Extensive experience in leading and managing multidisciplinary teams in global, matrixed environments.
• Demonstrated expertise in overseeing the end-to-end clinical trial process, ensuring timelines and standards are met.
• Strong track record of managing complexity and driving collaboration across dispersed organizations.