We are currently seeking a Trial Vendor Associate Director to be based in Dublin, Ireland. This is a hybrid office/home based position with 12 days per month to be performed from the office.
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).
About the RoleClose interaction and collaboration with study team lead and study team members during study lifetimeReview of vendor related protocol sections during protocol developmentManage interface with vendors in cooperation with vendor partner functionsQuote/proposal review in collaboration with procurement, support contract negotiations, if requiredContribute to the development of vendor contract amendments and accountable for vendor cost control, budget review, invoice reconciliation and PO close-outVendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trialCover all vendor activities after study start-up and all categories not covered by VSMs during start-upInitiate/co-ordinate vendor kick-off meeting for categories not covered by VSMsAttend vendor kick-off meeting for VSM supported categoriesOptimizing a frontloaded and timely study-start-up process, manage vendor-related activities for DB go livePerform user-acceptance testing (UAT) for eCOA and IRTDrive and monitor central vendor-related activities for site activation, compile Final Protocol Package (FPP) required documents centrally, monitor site activation progress and address related issues and riskCreates and maintains vendor-related risk maps with contingency plan for documentation in FIRSTInteract and collaborate with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)Key Responsibilities: 5+ years working experience and excellent knowledge of the clinical operation processes and vendor managementExcellent knowledge of GxP and ICH regulationsVery good knowledge of clinical trial design and mapping to supplier requirementsThorough and technical understanding of Novartis specifications for supplier provided servicesUser Acceptance testing for eCOA and IRTSite collaboration and site activationVendor management; outsourcing, contracting, sourcing, of clinical servicesResults-driven: demonstrated ability of completing projects on timeAbility to work in cross-functional teams and a matrixed environmentStrong influencing and negotiation skillsGood written and oral communications skillsVery good problem-solving skillsDemonstrated willingness to make decisions and to take responsibility for suchExcellent interpersonal skills (team player)Proven networking skills and ability to share knowledge and experience amongst colleagues
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