Job ID REQ-10030968 Dec 03, 2024 United Kingdom Summary When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare.

We are currently looking for a Trial Vendor Senior Manager to join our team in London.

This is a hybrid position with 12 days a month from our White City offices.

The main purpose of this position is to be accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. To collaborate with the VSM for the VSM’s category specific responsibilities and be 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.

As a Core member of the Clinical Trial Team (CTT) you will independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards, you will 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. You will proactively manage vendor-related risks and potential issues and implement global vendor strategy.

#LI-Hybrid 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 VSM 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, if requiredContributes to the development of vendor contract amendments • 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 trialCovers all vendor activities after study start-up and all categories not covered by VSMs during start-upInitiates/co-ordinates vendor kick-off meeting for categories not covered by VSMsAttends vendor kick-off meeting for VSM supported categoriesOptimizing a frontloaded and timely study-start-up process, manages vendor-related activities for DB go livePerforms user-acceptance testing (UAT) for eCOA and IRTDrives 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 riskCreates and maintains vendor-related risk maps with contingency plan for documentation in FIRSTManages system and portal user access for vendor, sponsor and site staff, maintain access logsUses Unified Vendor Portal (UVP) to manage vendorUses Clinical Insights to manage vendors and to achieve site readiness timelinesPlans and tracks supply delivery to sites and return of equipment from sitesInteracts 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 managementFollow-up with countries and hubs for their vendor-related risks and issuesDocument issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action

Essential 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? 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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture 

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division Development Business Unit Innovative Medicines Location United Kingdom Site London (The Westworks) Company / Legal Entity GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Alternative Location 1 Dublin (Country President Office (CPO)), Ireland Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Apply to Job

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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