RLT Supplies Operations Manager RSOM - Serbia - FSP
Serbia, Remote Job ID R0000024663 Category Clinical TrialsAbout this Role
Reporting to the Vendor Category Expert, the Vendor Startup Manager is responsible to provide technical expertise for the category throughout startup to close out to the VCE and indirectly to the Clinical Trial Team.
The RSOM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization and ensures compliance through the life of the studies assigned.
This role proactively assesses risk and concludes contingency plans to de-risk study startup and beyond.
Accountabilities:
The RSOM interacts closely with the VPM Vendor Program Manager providing category specific expertise to achieve study objectives specifically for its assigned categories:
RSOM accountabilities and responsibilities in close collaboration with the VCE and aligned to VPM managing other categories:
Reviewing of the vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications towards Final Protocol
Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors.
Quote/Proposal review in collaboration with procurement (and vendor). If required, support contract negotiations.
Vendor budget review of final quotes
Accountable for Vendor cost control, budget review, invoice reconciliation and PO close-out
Supports program overview by providing study demands to VCE
Ensures all submission documents are provided by vendor, as required, to countries participating in a study
Works closely with trial and monitoring teams to understand site requirements for study participation
Ensures changes to country and site plans are consistently shared with vendors and VCE for start up, resupply and close out. Supports amendment of vendor contracts with Procurement team
Optimizing a frontloaded and timely study start-up process in support of a timely site readiness
Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
Acts as escalation point for vendor-related query management
Pro-actively creates and maintains vendor related risk maps with contingency plan for documentation in FIRST
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 actions. Escalates issue if required to the Vendor Category Expert VCE.
Drive root cause analysis of supplier performance issues and look for trending
Supports the implementation of standards, templates, tools, and processes for vendors for defined categories in collaboration with the VCE
Using Unified Vendor Portal (UVP) to manage vendor service delivery
Supports practice leaders in improvement projects and learning loops
Collaborate across TRD, SSO and VPG to provide data for vendor qualification efforts
Review and approve invoices against activity
In partnership with the vendor, develop site and monitor training material, and attend/support training if needed
Activities & Interfaces:
Closely interacts with VCE and study team during startup, maintenance and close out
Collaborates with partner functions such as ESP QA, TRD QA and Procurement
With VCE: escalate risk and issues as needed, root cause analysis and CAPAs, standardization of service deliveries, evaluation and definition of category strategies
Consultation for Service / Category specific expertise
Share and process information i.e., lessons learned with ERMT and VCE, and contribute to best practice sharing activities
Leadership Capabilities:
Very strong vendor management skills
Demonstrated strategic skills; organizational knowledge; advanced planning and project management skills, as well as an advanced understanding of business processes.
Partnering skills with internal and external stakeholders
Strong problem solving, negotiation, deadline driven and conflict resolution skills
Strong influencing skills and timeline driven
Ideal Background:
Degree in science or business with equivalent experience
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
Expert knowledge of clinical trial design and mapping to supplier requirements
Thorough and technical understanding of Novartis specifications for supplier provided services
Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas
Demonstrated partnering across divisions with internal and external stakeholders
Demonstrated root cause analysis, problem solving, and solution generation skills
Experience in User Acceptance testing (eCOA & IRT)
Knowledge of key deliverables that impact green light milestones and vendor readiness
Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (RFP, RFQ, contracting)
Specific category expertise – ideally experience of global equipment supply and/or radiation
#LI-REMOTE
JOBS FOR YOU
There is no jobs to view
You currently have no saved jobs to view.
Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page..
More Than A Job
