For our client - a world renowned pharmaceutical company - we are looking for a Clinical Trial Admin Specialist!
Project Specialist, Temperature Management & Control (TM&C)
Department: Integrated Supply Chain Logistics – Clinical Supply Chain
Objectives and Responsibilities
This individual contributor is responsible for the management of clinical supplies (Drug Product and Finished Kits) during all phases of clinical trials consistent with Good Manufacturing, Distribution, and Clinical Practices (i.e. GxP guidelines), with a specific focus on Temperature Management & Control (TM&C).
Main Duties / Additional Duties / Sphere of authority
- Manage and prioritize temperature excursion submissions and other temperature related requests in the shared shared mailbox.
- Develop strong internal collaboration with Global Development, Drug Product Development, Analytical Development, Quality, Trial & Supply Management, Clinical Supply Integration, and Logistics stakeholders to ensure temperature excursions resolution and overall customer satisfaction.
- Customize protocol specific temperature out-of-range (TOR) forms based on product attributes
- Coordinate quote request and purchase order setup process to centrally source temperature monitoring devices.
- Support business process improvement initiatives.
- Support changes to the portfolio like new trials, products, and integrations.
- Identify opportunities for further integration with Logistics and if needed, support logistics.
- Quality Events (i.e. QI) process, with a focus on issues related to Temperature excursions.
Profile needed for this function
- 2-4 years of professional related business experience, preferably in a clinical supply related role (i.e. operations, logistics, quality, planning, development, supply chain).
- Pharma background is preferred.
- Knowledge of Clinical Supply Distribution, Clinical Study Execution, and GxP principles.
- Background in project management would be preferred.
- Experience with drafting SOPs.
- Highly organized with strong attention to detail.
- Acute sense of urgency for the tasks at hand, including ability to drive resolution with minimal management oversight.
- Ability to work effectively in a dynamic environment, handle multiple projects, and daily planned and unplanned operational activities.
- Excellent written and verbal communication skills.
- Workflow / Process oriented - stress resilient
- A minimum of a university/bachelor’s degree (or equivalent experience) is required
- Knowledge of English
Specific know how of systems
- Strong critical thinking skills
- Strong cross-functional coordination skills
- Excellent problem solving and decision-making skills
- Strong quality management skills
- Requires MS Office proficiency, specifically advanced Microsoft Excel skills
- Strong data analysis and problem-solving experience (e.g. use of Excel to analyze large sets of data via pivot tables, graphs, VLOOKUP, etc. to influence decision-making)
- Business applications experience is an advantage, such as SAP Ariba, Quality Event Management System (i.e. Trackwise), and/or Interactive Response Technology (i.e. IVRS) functionality
- Location: Beerse, Belgium
- Start-date: ASAP
- Hybrid position – 1 day onsite or fully remote
- Duration: 1-year initial contract
Send your CV to Khanyi Mabena at firstname.lastname@example.org or contact her on +31 2020 44502.