SUMMARY

As a core member of the Clinical Trial Team (CTT), the main purpose of this position is accountability for vendor service delivery at the study level to independently manage all clinical vendor related aspects of global clinical trial(s).

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
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  Division
  Development
  Business Unit
  Innovative Medicines
  Location
  Ireland
  Site
  Dublin (NOCC)
  Company / Legal Entity
  IE02 (FCRS = IE002) Novartis Ireland Ltd
  Functional Area
  Research & Development
  Job Type
  Full time
  Employment Type
  Regular
  Shift Work
  No
  Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

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.