Vendor Management Expertise Sought
This role is accountable for vendor service delivery at the study level.
* Closely collaborate with study team leads and members throughout the study lifecycle to ensure seamless integration of vendor services.
* Review vendor-related protocol sections during protocol development to guarantee alignment with clinical trial objectives.
* Manage vendor interfaces, support contract negotiations in collaboration with procurement, and oversee vendor cost control, budget reviews, invoice reconciliation, and PO close-out.
* Evaluate vendor performance, identifying areas for improvement and implementing corrective actions to maintain quality and service standards.
* Drive site activation, compile central documents, address risks/issues during site activation, and conduct user-acceptance testing (UAT) for eCOA and IRT systems.
* Monitor vendor-related cycle times and risks using tools like FIRST, while implementing proactive measures to mitigate potential issues.
Requirements
* 5+ years of experience with clinical operations and vendor management processes, with a proven track record of success.
* Strong understanding of GxP and ICH regulations, with ability to apply knowledge in a dynamic environment.
* Solid knowledge of clinical trial design and alignment to supplier requirements, with expertise in vendor management, including outsourcing, contracting, and sourcing clinical services.
* Results-oriented, with a strong ability to collaborate effectively in cross-functional teams within a matrixed environment, influencing, negotiating, communicating, and problem-solving skills.