Study Leader
Novartis
Summary
Contributes in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.
About the Role
Key responsibilities:
- Co-leads clinical trials, promotes operational excellence with agile principles, and ensures on-time delivery of studies.
- Fosters an agile culture within assigned studies to maximize collaboration and achieve long-term business impact.
- Collaborates with regulatory writing and clinical development to develop global clinical trial protocols and study-related documents.
- Maintains up-to-date study status, risks, and issues, and ensures readiness for inspections and audits.
- Oversees study recruitment and works closely with SSO Clinical Program Managers and Vendor Partnerships & Governance to deliver clinical study objectives.
- Ensures proper handling of all study close-out activities such as site close-outs and final drug accountability.
- Contributes to the development of clinical study reports, and partners with Portfolio Strategy & Planning to align studies with program strategy.
- Builds high-performing teams, fosters psychological safety, and serves as the single point of contact for internal/external customers.
Essential requirements:
- Bachelor's degree in life sciences or healthcare, with an advanced degree preferred.
- Minimum 2 years’ experience in clinical research or drug development in academic or industry environments, spanning Phases I to IV.
- At least 1 year experience conducting global clinical studies including planning, execution, and reporting, in compliance with international standards like GCP/ICH and health authorities' regulations.
- Experience managing teams in a complex, matrix, and global environment, preferably virtual teams.
- Demonstrated ability in building effective relationships with internal and external stakeholders.
- Strong communication and presentation skills, both oral and written.
- Proven organization and prioritization abilities, along with negotiation, conflict resolution, and an enterprise mindset.
- Strong project management skills, strategic thinking, and problem-solving abilities; knowledge of relevant therapeutic area is preferred.
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? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.