External Development Operations (EDO) Supplier Lead job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
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), EDO UH, 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 to line functions within Global Drug Development 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 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 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 reconciliation.
Bachelor's degree required; Relevant advanced degree (MBA, Pharm.D, MD or PhD preferred)
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) required
Expertise in clinical operations and management of outsourced trial activities required
Excellent understanding of clinical development and clinical operation processes
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