Clinical Operations Assistant

About the Role

We are seeking a Clinical Operations Assistant to provide critical administrative and logistical support to our clinical operations teams across all phases of clinical studies. Reporting directly to the Head of Clinical Operations, you will play a key role in ensuring accurate documentation, maintaining tracking systems, coordinating study supplies, and assisting with site activation and monitoring preparation.

If you are organized, detail-oriented, and passionate about advancing cancer research, this role is a great fit for you!

Work Location & Remote Policy

• Work Setup: Primarily remote / teleworking, with a requirement of minimum 1 day per week on-site (Brussels).

Key Responsibilities

• Project & Site Support: Develop project-related forms/templates, ensure timely distribution of materials to participating sites, and handle incoming project correspondence.
• Document Management: Collect, process, and file regulatory and site-activation documents (insurances, translations, delegation logs, protocol signature pages) in compliance with GCP standards. Maintain regular progress reporting on document collection.
• Supply Coordination: Coordinate Investigational Medicinal Product (IMP) and sample kit supplies to clinical sites, alongside handling reconciliation documentation.
• System & File Maintenance: Keep the Trial Master File (TMF), Clinical Trial Management System (CTMS), and study tracking tools fully updated.
• Audit & Monitoring Prep: Prepare materials for on-site monitoring visits, internal/external audits, final reconciliations, and document archiving.
• Process Improvement: Contribute to departmental efficiency by participating in expert task forces and identifying areas for process enhancement.

Qualifications & Skills

• Education: Bachelor’s degree, preferably in Life Sciences.
• Experience: Minimum 1 to 3 years of experience in a scientific or clinical research field.
• Technical Skills: Proficiency in MS Office tools (Word, Excel, PowerPoint). GCP certification is a strong plus.
• Soft Skills: Meticulous, highly organized, self-motivated, with excellent multi-tasking capabilities. Strong communication skills and a great team player.
• Languages: Excellent written and spoken English.