SSO Study Start-Up Manager

• Lead country study start-up strategy and plans, partnering with portfolio leads and global study team.
• Drive start-up timelines from country allocation through Green Light readiness, meeting committed milestones.
• Prepare and submit ethics committee packages; review informed consent forms and manage amendments and updates.
• Coordinate health authority submissions with regulatory partners; respond to deficiency letters promptly and accurately.
• Maintain high-quality Trial Master File documentation for inspection readiness; ensure accuracy, completeness, and traceability.
• Lead site selection and readiness, ensuring documentation supports initiation and subsequent drug release.
• Chair local start-up meetings, align vendors and stakeholders, and implement corrective actions to meet Novartis standards.

Essential Requirements

• Degree in a scientific or health discipline (advanced degree preferred with clinical trial or project management experience).
• Fluent written and spoken English; local language capability as needed for the country scope.
• Minimum five years of clinical operations experience, including project oversight and/or clinical trial monitoring.
• Strong understanding of clinical drug development, especially trial set-up, execution, and monitoring.
• Demonstrated ability to lead in a matrix environment and influence without direct reports.
• Knowledge of Good Clinical Practice and International Council for Harmonisation standards, plus health authority expectations and Novartis standards