Clinical Trial Assistant
An internationally renowned pharmaceutical company is currently advertising a Clinical Trial Assistant to their office in Beerse. This top 10 pharma company works across multiple sectors, including medical devices, pharmaceutical research, and consumer health. The vacancy offers an exciting opportunity to work with a company with over 100,000 professionals around the globe.
- Managing 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 trial.
- Acting as a single point of contact accountable for responding to business-critical Temperature needs.
- Managing and adjusting supply dispositions via inventory systems including IVR & IWR.
- Conducting issue resolution activities for the temperature excursion supply aspects of the clinical trials.
- Developing 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.
- Interfacing 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.
- Executing 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.
- Acting 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.
- Supporting business process improvement initiatives.
- Supporting changes to the portfolio like new trials, products, and integrations.
- Identifying opportunities for further integration with Logistics and support the QI process, with a focus on issues related to Temperature excursions.
- Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution within Pharma R&D portfolio.
Skills and Requirements:
- A minimum of a bachelor's degree is required.
- Proficiency in English and Dutch.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Andrea Rotmistrovsky at +44 203 854 0675 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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