EDO Supplier Lead/ Vendor Manager
- Experience Level
Fulfilling a central role within the CTT, the EDO Supplier Lead provides a single point of contact (SPOC) for supplier services at a trial level and is the first point for issue escalation during study start up, acting as a conduit for clear communication and robust daily oversight.
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 selection and study set up activities of suppliers (e.g. completing the Study Specification Worksheets (SSW), providing templates for request for proposal, supplier selection documents). .
- Drive timeline 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
- 8-10 years successful career track record in pharmaceutical clinical drug development and/or clinical supplier technology (BioPharma or with a CRO/Central Lab/Specialty Provider) including expertise in clinical operations and, management of outsourced trial activities
- Excellent understanding of clinical development and clinical operation processes
- Experience in central Lab and/or Biomarker
- Thorough understanding of supplier provided technology, media, tools, trends and adoption rates
- Good understanding of clinical research and development including, quality & regulatory standards and policies relevant to defined services.
- Demonstrated ability of completing projects on time and within budget.
- Strong influencing and negotiation skills.
- Good understanding of contracts and payment terms (including basic legal understanding of terms and conditions)
- Knowledge of clinical trial design
- Excellent problem-solving techniques/skills
- Excellent project management experience
- Excellent communication and presentation skills
- Expert in understanding trial related supplier marketplace (e.g. CRO/IRT/eCOA/Central Labs/Specialty Provider)
- Profound knowledge in finance (understanding of cost drivers for clinical trials) as it relates to contracts and cost reductions.
- Ability to work in a global team and matrix structure organization, meet timelines and work with minimal supervision
- Good knowledge of GCP, GMP and FDA part 11
- Excellent understanding of clinical trial methodology, GCP and medical terminology.
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