Global Clinical Operations - SSO Study Start-Up Country Head

Band

Level 6

 

Job Description Summary

The SSO Study Start-Up Country Head is accountable for the governance and oversight of the study start-up team in a standalone country. The SSO Study Start-Up Country Head is accountable for the country SSU strategy and prioritization in close collaboration with SSO Country/Cluster Head Portfolio and SSO Country Head to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.

 

Job Description

Key responsibilities:

Study Start-Up Strategy

• Collaborates with 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
• Defines and continuously optimizes country SSU strategy in close collaboration with SSO Country Head and SSO Country/Cluster Head Portfolio
• Accountable for timely start-up activities from country allocation until 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 SSO Country/Cluster Head Portfolio, SSO Portfolio Team Leads and global study team 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
• Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times

People and resource management

• Hiring, training, development, and retention of Study Start-Up team

• Resource management and reporting of Study Start-Up Team
• 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 university degree in scientific or health discipline required
• Fluent in both written and spoken English
• Fluent in both written and spoken country language
• Minimum 8 years’ experience in clinical operations and planning
• Minimum 4 years’ experience in people management and team leadership
• Excellent 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

Desirable requirements:

• Strong capability in working in a global/country matrix environment
• Proven successful leadership of teams, preferably with experience in working with international teams
• Strong interpersonal, negotiation and conflict resolution skills
• Communicates effectively in a local/global matrixed environment

 

Skills Desired

Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management