We are currently looking for a Trial Vendor Senior Manager (TVSM) to be based in Dublin.
This is a hybrid position with 12 days per month from the office.
#LI-Hybrid
As a 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, you’ll be accountable for vendor service delivery at study level and collaborate 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 leverage your technical and study start-up (SSU) expertise to ensure a timely study start-up. About the Role
Key responsibilities:
Close interaction and collaboration with study team lead and study team members during study lifetimeReview of vendor related protocol sections during protocol developmentCollaborate with Vendor Startup Manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no Vendor Start Up Manager is assigned to the category, drive the SSW completion.Manages interface with vendors in cooperation with vendor partner functionsQuote/proposal review in collaboration with procurement, support contract negotiations and contributes= to the development of vendor contract amendmentsAccountable for vendor cost control and vendor service excellenceInitiates/co-ordinates vendor kick-off meeting for categories not covered by Vendor Start Up ManagersAttends vendor kick-off meeting for Vendor Start Up Manager supported categoriesEssential requirements:
Bachelor degree or equivalent degree is required, with advanced degree preferred.Fluent English (oral and written)3+ 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.Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Division Development Business Unit Innovative Medicines Location Ireland Site Dublin (NOCC) Company / Legal Entity IE02 (FCRS = IE002) Novartis Ireland Ltd Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Apply to JobNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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