IQVIA EDO Supplier Lead in Warsaw, Poland
The EDO Supplier Lead is a member of the Clinical Trial Team (CTT) accountable to identify, select, and manage performance of external service suppliers (such as CROs, central laboratory, cardiac safety, IRT, eCOA, spirometry, and patient recruitment and retention suppliers) in collaboration with Global Trial Director (GTD), GH ERM, Procurement, and the Quality Assurance teams (QA) to assure the delivery of quality, timely and cost-effective external deliverables and services to support the Global Drug Development (GDD) pipeline.
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.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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