Global Clinical Operations- Study Start-Up Team Lead

Key responsibilities:

Study Start-Up Strategy

• Supports Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact
• Seeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operations
• Supports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)
• Responsible for timely start-up activities from country allocation until site Green Light (ready-to-initiate-sites)
• Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable

Allocation, initiation and conduct of trials

• Collaborates with Head Portfolio, SSO Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead) to ensure SSU timelines and deliverables are met according to country commitments
• Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Implements innovative and efficient processes which are in line with Novartis strategy

People and resource management

• Hiring, training, development, and retention of Study Start-Up associates
• Resource management and reporting of Study Start-Up associates
• Ensures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives
• Manages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions

Essential requirements:

• A degree in scientific or health discipline required
• Fluent in both written and spoken English
• Fluent in both written and spoken country language
• Minimum 5 years’ experience in clinical operations and planning
• Proven leadership capabilities and experience (with or without direct line management responsibilities).
• Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
• Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/national Health Authorities regulations and Novartis standards
• Strong capability in working in a global/country matrix environment

Desirable requirements:

• Proven successful leadership of teams (with or without direct reports), preferably with experience in working with international teams
• Strong interpersonal, negotiation and conflict resolution skills Communicates effectively in a local/global matrixed environment