Job title: EDO Coordinator
Job description: .Job Purpose
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, imaging, eCOA 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 all supplier services at a trial level and is the first point for issue escalation, 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 contracting 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 outsourcing and selection of suppliers (e.g. completing the Study Specification Worksheets (SSW), providing templates for request for proposal, supplier selection documents). If required, support contract negotiations.
Drive timeline and deliverable management of all external activities from
identification of supplier needs through closeout and final invoices.
Support budget management by tracking work performed against contract to
support CTT with review, approval and processing of invoices.
Depending on outsourced service, perform testing and validation (User
Acceptance Testing) to ensure final system programming meet service
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 accountalbe 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 and investigator meetings.
At study close out, accountable to ensure proper and complete supplier related activities are managed to allow timely study closure and appropriate
Key Performance Indicators (Indicate how performance for this role will be
Contributes to trial level milestones related to supplier deliverable/performance such as submission deadlines, FPFV milestones or other service related targets.
Accountability for external spend forecast accuracy at TFR Trial Forecasting
and Resource Management related workstreams.
Contributes to trial timelines by managing supplier’s delivery performance.
Manages supplier budget and invoicing with timly payment for services performed
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
Job Dimensions (Indicate key facts and figures)
Number of associates: N/A
(Budget, Cost, Sales, etc.Potential budget management of contracts upto
~30MUSDImpact on the organization:
Major: Leads and drives daily interactions and delivery of external services for multiple clinical trials.
Contribute to the successful completion of trial activities through supplier selection, contracting and performance management which enable CTTs to fulfill expectations of deliverables according to agreed timelines and budget.
Ensuring external quality reputation of Novartis and minimizing compliance and regulatory risks of outsourced services.
High: Contributes to GDD productivity objectives and
overall optimization of supplier performance and
Ideal Background (State the preferred education and experience level)
Bachelor’s degree required; Relevant advanced degree
(MBA, Pharm.D, MD or PhD preferred)
Languages: English: fluent written and spoken
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
Thorough understanding of supplier provided
technology, media, tools, trends and adoption
Good understanding of clinical research and
development including, quality & regulatory
standards and policies relevant to defined
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/Central Labs/Specialty
Profound knowledge in finance
(understanding of cost drivers for clinical
trials) as it relates to contracts and cost
Ability to work in a global team and matrix structure organization, meet timelines and work with
Good knowledge of GCP, GMP and FDA part 11
Excellent understanding of clinical trial
methodology, GCP and medical terminology.
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
Location: Thane, Maharashtra
Job date: Mon, 11 Apr 2022 06:23:49 GMT
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