Job Description:
This individual contributor is responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies.
Description of the Role
•Responsible for management of all temperature excursions associated to clinical supplies during the trial execution ensuring prompt resolution and compliance with all SOP, GMP, Quality, and Regulatory guidelines, contributing to successful subject dosing within Pharma R&D for all phases of clinical trials
•Act as a single point of contact accountable for the business critical need
•Manage and adjust supply dispositions via inventory systems including IVR & IWR
•Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials
•Develop strong internal collaboration with GCO, DPD, and Quality stakeholders to ensure TOR resolution and overall customer satisfaction
•Interface with Global Trial Managers, Trial Supply Managers, Drug Product Development, and Quality to manage trial supply temperature excursions
•Responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within Pharma R&D for all phases of clinical trials
•Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP
•Act as subject matter experts for temperature management requirements including storage and monitoring capabilities
•Customizing protocol specific temperature out-of-range forms based on product attributes
•Coordinating quote request and PO setup process to centrally source temperature monitoring devices
•Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction
•Partner with Global Trial Managers, Local Trial Managers, Site Managers, Local Medication Coordinators, Clinical Supplies Design Leaders, and Central Business Operations in temperature management and issue resolution
•Supports business process improvement initiatives.
Focus and Scope
Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution
Critical Experiences Required
• A university/bachelor’s degree (or equivalent experience) is required. Generally, requires 2+ years related experience.
•Experience with quality system tools preferred (e.g. Trackwise)
•Experience with Interactive Response Technologies for Clinical Trials (e.g. inventory management functionality)
•Experience with the following functions preferred: clinical operations, logistics, quality assurance, clinical supply chain planning, drug product development
•Demonstrated knowledge in the following areas:
•Clinical Supply Distribution
•Clinical Study Execution/GCP
•Intermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint)
•Experience in a highly matrixes environment (preferred)
Critical Competencies:
•Very strong data analysis and problem solving experience
•Highly organized with strong attention to detail
•Extreme sense of urgency for the tasks at hand, including ability to drive resolution with minimal management oversight
•Excellent written and verbal communication skills
•Task oriented (repetitive process)
•Strong quality management skills
•Strong strategic thinking skills
•Excellent problem solving and decision making skills
•Strong cross-functional coordination skills