Trial Vendor Senior Manager

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.

Trial Vendor Senior Manager

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, 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 manage 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 the 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. Key responsibilities:

• Close interaction and collaboration with study team lead and study team members during study lifetime
• Review of vendor-related protocol sections during protocol development
• Collaborate 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.
• Manage interface with vendors in cooperation with vendor partner functions
• Quote/proposal review in collaboration with procurement, support contract negotiations, if required
• Contribute to the development of vendor contract amendments
• Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
• Ensure vendors meet quality and service level standards in their service delivery for the trial
• Cover all vendor activities after study start-up and all categories not covered by VSMs during start-up
• Initiate/co-ordinate vendor kick-off meeting for categories not covered by VSMs
• Attend vendor kick-off meeting for VSM supported categories
• Optimize a frontloaded and timely study-start-up process, manage vendor-related activities for DB go live
• Perform user-acceptance testing (UAT) for eCOA and IRT
• Drive 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 risk
• Create and maintain vendor-related risk maps with contingency plan for documentation
• Manage system and portal user access for vendor, sponsor and site staff, maintain access logs
• Use Unified Vendor Portal (UVP) to manage vendor
• Use Clinical Insights to manage vendors and to achieve site readiness timelines
• Plan and track supply delivery to sites and return of equipment from sites
• Interact and collaborate with Data Ops, review vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)
• Act as escalation point for vendor-related query management
• Follow-up with countries and hubs for their vendor-related risks and issues
• Document issues identified with vendor oversight/performance in the FIRST tool and implement and monitor 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 clinical operation processes and vendor management
• Excellent knowledge of GxP and ICH regulations
• Very good knowledge of clinical trial design and mapping to supplier requirements
• Thorough and technical understanding of Novartis specifications for supplier provided services
• User Acceptance testing for eCOA and IRT
• Site collaboration and site activation
• Vendor management; outsourcing, contracting, sourcing of clinical services
• Results-driven: demonstrated ability of completing projects on time
• Ability to work in cross-functional teams and a matrixed environment
• Strong influencing and negotiation skills
• Good written and oral communications skills
• Very good problem-solving skills
• Demonstrated willingness to make decisions and to take responsibility for such
• Excellent 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! 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.