Clinical Study Admin & Master File Specialist

Johnson & Johnson; Machelen; Sur place; EUR 21 000 - 34 000; Plein temps

Résumé du poste

Johnson & Johnson MedTech in Belgium is seeking an Administrative Support Specialist to assist clinical study staff and keep Trial Master Files in order. You will process, track, and file essential documents, and liaise with the Clinical R&D team to ensure regulatory compliance.

This contract role emphasizes attention to detail, strong communication, and proficiency with Microsoft Office and CTMS systems, with opportunities to contribute to process improvements and study operations.

Qualifications

• At least 1 year of administrative support experience.
• Clinical research experience is a plus.
• Clinical/medical background is a plus.
• Proficient with Microsoft Office (Excel, Word, PowerPoint).
• Strong tracking, written and verbal communication, and organizational skills.

Responsabilités

• Track and file study documents and manage Trial Master File.
• Create/distribute regulatory binders and the wet-ink signed documents binder.
• Assist study staff and investigators to resolve issues related to Study Files and implement corrective actions.
• Support internal communication of important clinical data and events.
• Support ongoing use of (one)CTMS by maintaining and tracking activities.
• Provide safety documentation to other functional groups for safety committee meetings.
• Assist with study supplies creation, ordering and distribution to sites.
• Assist with device tracking and ordering if required.
• Assist with Investigator meetings/expert panel meetings.
• Distribute newsletters by creating mailing lists and routing for approvals.
• Participate in process improvements for (one)CTMS/vTMF.

Description du poste

Johnson & Johnson MedTech in Belgium is seeking an Administrative Support Specialist to assist clinical study staff and keep Trial Master Files in order. You will process, track, and file essential documents, and liaise with the Clinical R&D team to ensure regulatory compliance.

This contract role emphasizes attention to detail, strong communication, and proficiency with Microsoft Office and CTMS systems, with opportunities to contribute to process improvements and study operations.