EDO Supplier Lead
Accountable as SPOC for managing daily supplier oversight and management at the CTT level:
• Accountable to the CTT and other line functions within GDD in related processes and activities of identification, qualification, selection and study set up for Suppliers.
• Collaborate with the EDO Relationship Leads to support supplier governance and oversight for qualified suppliers through documented performance and issue management.
• Accountable to the CTT in the process of study set up activities of suppliers (e.g. completing the Study Specification Worksheets (SSW), providing templates for request for proposal, and providing input to supplier selection documents).
• Drive timelines and deliverable management of all external activities from identification of supplier needs to global set up of suppliers.
• Depending on outsourced service, perform testing and validation (User Acceptance Testing) to ensure final system programming meet service requirements.
• Evaluate, document, track and manage performance and oversight of Suppliers with input from CTTs, using appropriate tools.
• Accountable to the CTT to ensure changes to protocol, allocation or other study designs are consistently shared and incorporated into supplier budgets, timelines, and specifications.
• Intervene and accountable to the CTTs in Supplier issue management. Escalate issues that could present a risk to the patient safety, validity/integrity of data, regulatory acceptance and/or to Novartis business reputation in timely manner in accordance to relevant procedures.
• Responsible for ensuring supplier compliance with NVS SOPs and business guidance. Responsible, in partnership with QA, to document trial level deviations and perform Root Cause Analysis (RCA) and CAPAs as appropriate.
• Support the development and implementation of process changes and standards to continuously improve and optimize interaction by assessing trends, quality issues, and contract issues driving suppliers’ quality improvement.
• Participate in CTT meetings when required to provide overview and update on supplier deliverables.
• As required create appropriate training for CTT members and Suppliers for CTT Kick Off.
• Accountable to ensure proper and complete supplier related activities and documentations are managed to allow timely global supplier set up.
Key Performance Indicators:
• Contributes to trial level milestones related to supplier deliverable/performance such as submission deadlines, FPFV milestones or other service related targets.
• Contributes to trial timelines by managing supplier’s delivery performance.
• Documented supplier oversight and robust issue escalation
• Supplier’s trial level KPI/KQI performance.
• Participates in decision making sessions with other key internal partners and collaborates successfully with key internal/external key partners.
• Defines and shares best practices and standards for cross-divisional operations within EDO.
• Excellent working relationships with Suppliers, Procurement, Quality, and CTT.
• Quality supplier set up for study start up services
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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