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Clinical Trial Assistant

Pauwels Consulting | Antwerp | Permanent, Independent, Full-time

Published on Jobat.be 9 days ago

Pauwels Consulting is a Belgian consulting firm with more than 520 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

Clinical Trial Assistant

Job description

  • 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 R&D for all phases of clinical trials
  • Act as a single point of contact accountable for responding to business critical Temperature needs
  • 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 Global Clincial Operations (GCO), Drug Product Development (DPD), Analytical Development (AD), Quality, Trial & Supply Management (T&SM), Clinical Supply Integration (CSI), and Logistics stakeholders to ensure TOR resolution and overall customer satisfaction
  • Interface with Global Trial Managers, Local Trial Managers, Site Managers, Local Medication Coordinators, Trial Supply Managers, Clinical Supplies Integrators, Drug Product Development, Quality, and Logistics Integrators to manage trial supply temperature excursions and issue resolution
  • Responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within R&D for all phases of clinical trials
  • 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
  • Supports business process improvement initiatives
  • Supports changes to the portfolio like new trials, products, and integrations
  • Identify opportunities for further integration with Logistics and support the QI process, with a focus on issues related to Temperature excursions

Profile

  • English and Dutch spoken and written
  • Relevant Master's or Bachelor's degree
  • Previous CTA experience is a plus

Offer

  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

More info

Bezoek pauwelsconsulting.com voor meer informatie over de vacature Clinical Trial Assistant of solliciteer online op de vacature Clinical Trial Assistant.

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    Characteristics

    Requirements

    • Academic Bachelor

    Offer

    • Permanent
    • Independent
    • Full-time
    • Company car

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