【Job Description Summary】
Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) during study start-up, and leverages effectively their technical and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, escalates vendor issues to the VSM while keeping Vendor Program Strategy Directors informed about risks, issues, and study progress. Oversees vendor compliance at study level.
【Job Description】
■Key Responsibilities:
Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the category specific responsibilities. 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.
Assigned responsibilities can include but are not limited to:
• Close interaction and collaboration with study team lead and study team members during study lifetime
• Review of vendor related protocol sections during protocol development
• Collaborate with Vendor Startup Manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion.
• Manages interface with vendors in cooperation with vendor partner functions
• Quote/proposal review in collaboration with procurement, support contract negotiations, if required
• Contributes to the development of vendor contract amendments
• Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
• Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
• Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
• Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs
• Attends vendor kick-off meeting for VSM supported categories
• Optimizing a frontloaded and timely study-start-up process, manages vendor-related activities for DB go live
• Performs user-acceptance testing (UAT) for eCOA and IRT
• Drives and monitors central vendor-related activities for site activation, compiles Final Protocol Package (FPP) required documents centrally, monitors site activation progress and addresses related issues and risk
• Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST
• Manages system and portal user access for vendor, sponsor and site staff, maintain access logs
• Uses Unified Vendor Portal (UVP) to manage vendor
• Uses Clinical Insights to manage vendors and to achieve site readiness timelines
• Plans and tracks supply delivery to sites and return of equipment from sites
• Interacts and collaborates with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)
• Acts as escalation point for vendor-related query management
• Follow-up with countries and hubs for their vendor-related risks and issues
• Document issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action
■休日：完全週休二日制
