clinical study administrator.

We are looking for an independent, proactive candidate who meets the following criteria:

• Education: Minimum of a Bachelor’s Degree.
• Experience: At least 1 year of administrative support experience. Previous experience in clinical study administration or a medical background is highly preferred.
• Technical Skills: Proficiency in Microsoft Office tools, specifically Excel, Word, and PowerPoint.
• Languages: Fluent in English (spoken and written); knowledge of any other European language is a distinct advantage.
• Competencies: Exceptional attention to detail, strong organizational skills, and excellent written/verbal communication.
• Availability: Ability to work full-time at Diegem/Zaventem

As a Clinical Study Administrator, you will dedicate the majority of your time (85%) to clinical study administrative tasks, with the remaining 15% focused on broader departmental support. Your key activities will include:

• Documentation Management: Accountable for the timely tracking, filing, and processing of study essential documents.
• Trial Master File (TMF): Building and maintaining the TMF (including v-TMF) and ensuring completeness according to regulations and departmental guidelines.
• Systems & Tracking: Using (one)CTMS for building and tracking relevant study activities and clinical data.
• Regulatory Support: Creating and distributing regulatory binders and wet-ink signed document binders.
• Collaborative Problem Solving: Assisting investigators and study staff to resolve issues relating to Study Files and implementing corrective actions.
• Logistics & Support: Assisting with investigator meetings, safety documentation for committee meetings, and the distribution of study supplies or newsletters.

• Bachelors or equivalent