Trial Vendor Senior Manager (TVSM)
Trial Vendor Senior Manager (TVSM)
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Job Description
Job Description 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 VSMs 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
Job Description
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.
Manages interface with vendors in cooperation with vendor partner functions
Quote/proposal review in collaboration with procurement support contract negotiations if required
Contributes to the development of vendor contract amendments Accountable for vendor cost control budget review invoice reconciliation and PO close-out
Vendor service excellence at study level ensures vendors meet quality and service level standards in their service delivery for the trial
Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs
Attends vendor kick-off meeting for VSM supported categories
Optimizing a frontloaded and timely study-start-up process manages vendor-related activities for DB go live
Performs user-acceptance testing (UAT) for eCOA and IRT
Drives 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 risk
Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST
Manages system and portal user access for vendor sponsor and site staff maintain access logs
Uses Unified Vendor Portal (UVP) to manage vendor
Uses Clinical Insights to manage vendors and to achieve site readiness timelines
Plans and tracks supply delivery to sites and return of equipment from sites
Interacts 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 management
Follow-up with countries and hubs for their vendor-related risks and issues
Document 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 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 peoples 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: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. 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.
Skills Desired
Budget Management Clinical Trials Negotiation Skills Process Improvement Project Planning Vendor Management Waterfall Project ManagementRequired Experience:
Senior Manager
Employment Type
Full-Time
