Clinical Trials Assistant, Multi-Sponsor, Belgium

IQVIA; Zaventem; Sur place; EUR 32 000 - 46 000; Plein temps

Résumé du poste

IQVIA in Belgium is seeking an Administrative Assistant to support Clinical Research Associates and Regulatory and Start-Up teams, ensuring timely TMF delivery and document control.

You will assist with document handling, archiving, and site communications, while maintaining accuracy and compliance with GCP/ICH guidelines. Excellent language skills and Microsoft Office proficiency are required.

Qualifications

• High School Diploma or equivalent.
• Equivalent combination of education, training and experience.
• Computer skills including Word, Excel and PowerPoint.
• Written and verbal communication in English, Dutch and French.

Responsabilités

• Assist CRAs and RSU with updating and maintaining TMF and related documents.
• Assist with preparation, handling and archiving of clinical documentation and reports.
• Assist with periodic review of study files for completeness.
• Assist with distribution of Clinical Trial Supplies and tracking information.
• Assist with tracking of Case Report Forms and data flow.
• Act as central contact for project communications and documentation.
• May accompany CRAs on site visits to assist with monitoring duties after training.

Connaissances

English language

Dutch language

French language

Time management

Formation

High School Diploma or equivalent

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications

• High School Diploma or equivalent.
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including very good command of English, Dutch and French languages.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.