Study Start-up Team Lead

The Study Start-up Team Lead (SSU Team Lead) is responsible for overseeing a country study start-up managers team. We are seeking a dynamic and experienced individual to join our team. This role reports directly to the Study Start Up (SSU) Country Head and involves leading, mentoring, and governing the Study Start-Up Managers (SSUM) team, which is crucial for the success of our clinical trials.

Key responsibilities include leading local study start-up activities, ensuring timely trial initiation, and collaborating closely with leadership to deliver operational excellence in compliance with Novartis standards, ICH/GCP, and regulatory requirements.



The role also involves contributing to the strategic planning and prioritization of country SSU activities and being a member of the Italian SSO extended Leadership Team.

About the Role

The SSU Team Lead ensures process efficiency and drives innovation, while managing and developing the SSUM team to foster a culture of excellence and accountability. Responsibilities include:

1. Supporting the Study & Site Operations SSU Leadership Team to optimize country operations and enhance study start-up performance.
2. Implementing innovative practices to improve operational excellence, study start-up activities, and overall trial performance.
3. Collaborating with global and country teams to meet SSU timelines and deliverables, ensuring documentation and compliance standards are maintained.
4. Managing people, resources, and budgets effectively, and overseeing operational planning and execution.

Background

Candidates should have a degree in a scientific or health discipline, fluency in English, and at least 5 years of experience in clinical research or project management, including 4 years in personnel management. Deep knowledge of clinical trial regulations, GCP, and health authority requirements is essential.

Skills

- Project Management: Ability to manage multiple projects and timelines effectively.
- Problem Solving: Strong analytical skills and decision-making capabilities under pressure.
- Regulatory Knowledge: In-depth understanding of GCP, ICH guidelines,



and regulatory standards.
- Collaboration: Effective teamwork and interpersonal skills for cross-functional collaboration.
- Leadership: Proven ability to lead, mentor, and develop high-performing teams.

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