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).

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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.
• 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.

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