Clinical Trial Supplier Lead - FSP

Execupharm, a Parexel company are currently recruiting for an experienced clinical vendor/supplier lead to join our team in either the UK, Spain or India. In this role you’ll be singularly assigned to one of our largest sponsor clients.

The Clinical Trial SL (CTSL) supports the Clinical Trial Team to Identify, select, and manage performance of 3rd party suppliers in collaboration with Global Trial Director, External Development Operations Unit Head, Procurement, and the Quality Assurance teams to assure the delivery of quality, timely and cost-effective external resources and services to support the Global Drug Development pipeline.

In addition, each CTSL provides a single point of contact 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.

Primary Duties:

Accountable as SPOC for managing daily supplier oversight and management at the CTT level: Provide guidance to CTT and other line functions within GDD in related processes and activities of identification, qualification, selection and contracting Suppliers. Collaborate with the EDO 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, 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 CTT 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 client business reputation in timely manner in accordance to relevant procedures. Responsible for ensuring supplier compliance with client SOPs and business guidance. Partner 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. 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. Participate in client initiatives and continuous improvement objectives which require subject matter expertise from EDO SL. QualificationsSkills and Education:

Bachelor’s degree is required. Degree in life sciences, pharmacy preferred. Relevant advanced degree desirable (MBA, Pharm.D, MD or PhD preferred) End to end experience managing vendors in either IRT, eCOA or Central Labs category is essential. Excellent 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. Good understanding of contracts and payment terms (including basic legal understanding of terms and conditions). Profound knowledge in finance (understanding of cost drivers for clinical trials) as it relates to contracts and cost reductions.