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Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. To collaborate with the Vendor Start-up Manager (VSM) for the VSM’s category specific responsibilities and be responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Job Responsibility:
Collaborate closely with the study team lead and members throughout the study lifecycle
Review vendor-related protocol sections during protocol development
Drive or support the development and completion of Study Specification Worksheet (SSW) to facilitate vendor bid processes
Manage vendor interfaces in cooperation with partner functions, including quote reviews and contract negotiations
Oversee vendor cost control, budget reviews, invoice reconciliation, and purchase order (PO) close-out
Ensure vendor service excellence at the study level, meeting quality and service standards
Optimize study start-up processes and manage central vendor-related activities (e.g., site activation, supply tracking)
Monitor vendor risk and performance using tools such as FIRST, Unified Vendor Portal (UVP), and Clinical Insights, implementing corrective actions as needed
Requirements:
Bachelor’s degree or equivalent
advanced degree preferred
Fluency in English (oral and written)
Minimum of 3 years’ experience in clinical operations and vendor management processes
Strong knowledge of Good Practice (GxP) and International Council for Harmonization (ICH) regulations, clinical trial design, and supplier service specifications
Proficiency in vendor management, contracting, and site-related collaborations, including Information Technology Service Management (UAT) for eCOA and IRT systems
Results-driven with proven ability to complete projects within timelines
Excellent interpersonal, negotiation, problem-solving, and communication skills in a matrixed environment
Demonstrated networking abilities, team collaboration, and decision-making capabilities