Temperature Management Coordinator – Klein Management Systems – Malvern, PA, USA
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.
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 Janssen 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 Janssen Pharma R&D for all phases of clinical trials
Review and approval of all lnvestigational 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 mqnitoring 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
Suooorts business process improvement initiatives.
Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution within the Janssen Pharma R&D portfolio.
A minimum of a High School Diploma (Bachelors Degree preferred) and two years experience in a multi-disciplinary environment or Pharma R&D area is highly preferred, but not mandatory
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 hiqhly matrixed environment (preferred)
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
Click here for more information.
