EDO Relationship Lead

Primary Duties:

Accountable for managing daily supplier oversight and management at the Clinical Trial Team (CTT) level:Provide guidance to CTT and other line functions in related processes and activities of identification, qualification, selection and contracting Suppliers.Collaborate with the External Development Operations Managers to provide data to maintain and update qualified and preferred Suppliers list.Support Clinical Trial Teams and Procurement in the process of outsourcing to the Suppliers (e.g. completing the Study Specification Worksheets (SSW), providing templates for request for proposal, and supplier selection documents). If required, support contract negotiations and selection process.Drive timeline and deliverable management of all external activities from identification of supplier needs through closeout and final invoices.Support budget management, if requested, by tracking work performed against contract to support Clinical Trial Team with review, approval and processing of invoices.Depending on outsourced service, perform testing and validation (User Acceptance Testing) to ensure required specifications meet service requirements.Evaluate performance and demonstrate oversight of Suppliers with input from Clinical Trial Teams through operational Key Performance Indicators (KPI) trending and documented issue management using appropriate tools.Support CTT by ensuring changes to protocol, allocation or other study designs are consistently shared and incorporated into supplier budgets, timelines, and specifications.Intervene and support Clinical Trial Teams in case of issues with Suppliers. 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.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 work with suppliers to ensure proper and complete activities to allow timely study closure and appropriate reconciliation.

Skills and Education:Bachelor’s degree is required. Degree in life sciences, pharmacy preferred. Relevant advanced degree desirable (MBA, Pharm.D, MD or PhD preferred)English: fluent written and spoken5+ years relevant industry experience (BioPharma or with a CRO/Central Lab/Specialty Provider) including expertise in clinical operations and, management of outsourced trial activities.Strong technical and problem solving skillsExcellent understanding of clinical trial methodology, GCP and medical terminology.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.

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