| || • Ensure high quality global clinical operational input into biosimilar clinical development plans, outsourcing strategies, and trial execution plans.
• Align overall program and trial operational prioritization regarding resources and budget, including CRMA supports and outsourcing strategy in collaboration with Clinical Development Units, Global Medical Affairs, and other Biopharma Development; including adjustments as program priorities or strategies evolve.
• Provide guidance to Global Operational and CRMA Leaders across global sites to ensure timely and efficient operational execution of associated biosimilar clinical programs/trials.
• Establish culture of continuous process improvement and establish best practices in biosimilar clinical program and trial management.
• Partner and collaborate with other Novartis divisions to realize synergies and drive efficiencies and quality standards in biosimilar trial execution.
• Develop expertise and ensure quality and compliance with GCP and Pharmacovigilance requirements within Clinical Operations, collaborate with Clinical Quality Assurance for audits and inspections, and in particular response to inspection reports