Clinical Vendor Manager

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Clinical Vendor Manager12 monthsRemote / ReadingUp to £500 per day via Umbrella University degree or comparable education with several years of experience in the area of clinical development. In-depth knowledge of clinical development and drug development process, ICH-GCP, applicable legal, compliance and regulatory requirements as well as experience with contracts and vendors, and Project Management experience are also required.Major Tasks:First point of contact for different stakeholders (such as Study Team functions, SSM, Category Leads, Contract management and similar) regarding supplier management topics.Link between the Procurement organization and the CO operational functions to coordinate supplier qualification and maintain supplier performance including reliable documentationHolistic oversight of external suppliers used/contracted in CO (incl.insourcedARO,CRO) forinterventional clinical studies Manages supplier performance in a holistic way across trials.Responsible for continuous quality evaluation of Service Provider in cooperation with Study Team, PRO and AuditLeads and manages reviews of quality evaluation of a pool of preferred suppliers for CO outsourced servicesMaintains list of potential suppliers and qualified services and advises Study Teams and other stakeholders on use and performanceDrives performance assessment/feedback in databases (e.g. via supplier satisfaction feedback from Study Teams, Lessons Learned) and stores documents in databases including documentation for audits and inspectionsProvides guidance on supplier quality based on feedback from qualifications process and potential change of service after performance assessmentActs as point of contact for escalation of quality issues with suppliers in trials.Drives external partner qualification in cooperation with PRO and Audit Supplier KOM participation depending on trial needs and vendor specificIdentifies and informs stakeholders on decision/request to qualify supplier serviceDevelops qualification plan including timelines based on GCT agreed qualification scopeSets up qualification team consisting of core team and subject matter expertsRe-confirms qualification scope with GCT via CPMSelects qualification questionnaires and assigns tasksCollects input from the pre-agreed RPsFiles qualification documentation including completed questionnaires on Supplier Qualification SPLeads Qualification Team and drives agreement on supplier service qualificationEnsures qualification follow up items are completed and documentedMaintains tools for supplier qualificationProvides feedback loop for QSDs dealing with management of suppliers.Supports process improvement activities within related to Supplier ManagementSupports Study Teams with regard to scope definition