Job Description Summary 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).
Job Description Close 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 colleaguesWhy Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to ****** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Skills Desired: Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Project Management
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