Summary
#LI-HYBRID
About the Role
Key Responsibilities:
- Collaborate closely with study team lead and members throughout the study lifecycle.
- Review vendor-related protocol sections during protocol development. Manage vendor interfaces and support contract negotiations in collaboration with procurement.
- Oversee vendor cost control, budget reviews, invoice reconciliation, and PO close-out.
- Ensure vendor service excellence, maintaining quality and service standards at the study level.
- Drive site activation, compile central documents, and address risks/issues during site activation.
- Conduct user-acceptance testing (UAT) for eCOA and IRT systems.
- Monitor vendor-related cycle times and risks using tools like FIRST, while implementing corrective actions as needed.
Essential Requirements:
- 5+ years of experience with clinical operations and vendor management processes.
- Strong understanding of GxP and ICH regulations.
- Solid knowledge of clinical trial design and alignment to supplier requirements.
- Experience conducting User Acceptance Testing (UAT) for eCOA and IRT systems.
- Proven expertise in vendor management, including outsourcing, contracting, and sourcing clinical services.
- Results-oriented, with a track record of completing projects on time.
- Ability to collaborate effectively in cross-functional teams within a matrixed environment.
- Strong influencing, negotiation, communication, and problem-solving skills.
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
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: https://talentnetwork.novartis.com/network
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.
