SSO Study Start Up Country Head

Job Description Summary

Leads the strategic and operational planning/ management from a clinical trial execution perspective. Complete oversight of budget and resource allocation for the assigned programs. Drives operational excellence through process improvement and knowledge sharing across the function. Fosters an empowered organization which can navigate in a matrix environment and adjust quickly to business needs.

Job Description

Location: London, The Westworks Hybrid

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.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates who drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

Skills Desired

Accountability, Business Objectives, Collaboration, Leadership, Operational Excellence, Resource Management, Startup Strategy, Strategic Objectives, Study Start Up