About the Role

The SSU Team Lead ensures that processes and goals are met and actively drives innovation and simplification processes while also playing a crucial people management role by mentoring and developing the SSUM team, fostering a culture of excellence and accountability.

Your responsibilities include, but are not limited to:

Study Start-Up Strategy

• Supports 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.
• Supports country SSU strategy in close collaboration with SSU 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, Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead, SSU 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 SSU Managers
• Resource management and reporting of SSU Managers
• 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
• Interfaces with global trial execution organization through Global SSU managers for all portfolio deliverables.

Minimum requirements:

• A degree in scientific or health discipline required
• Minimum 5 years’ experience in clinical operations and planning
• Fluent in both written and spoken English and country language
• 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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

You will receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities. 

Commitment to Diversity and Inclusion:  Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.