Clinical Trials Support Specialist (TMF & Compliance)

IQVIA; Brussel; Sur place; EUR 25 000 - 35 000; Plein temps

Résumé du poste

IQVIA is seeking an administrative professional to support TMF and trial documentation coordination within the Clinical Research framework in Belgium. You will collaborate with CRAs and RSU teams to ensure timely and accurate clinical records and reporting.

The role emphasizes attention to regulatory standards (GCP/ICH) and strong document control skills, with on-site support and potential site visits after training. Proficiency in English, Dutch, and French is required.

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.

Responsabilités

• 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.

Connaissances

MS Word

Excel

PowerPoint

English

Dutch

French

Formation

High School Diploma

Equivalent combination of education, training and experience

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

IQVIA is seeking an administrative professional to support TMF and trial documentation coordination within the Clinical Research framework in Belgium. You will collaborate with CRAs and RSU teams to ensure timely and accurate clinical records and reporting.

The role emphasizes attention to regulatory standards (GCP/ICH) and strong document control skills, with on-site support and potential site visits after training. Proficiency in English, Dutch, and French is required.