Senior Clinical Trial Associate

Department: Clinical Development

Employment Type: Permanent - Full Time

Location: Antwerpen, Antwerp, Agomab Antwerp, Hybrid

Key Responsibilities

• Assist the CTM in the preparation, distribution and maintenance of study related documents;
• Manage the Trial Master File (TMF) to ensure completeness, accuracy and compliance with internal procedures and regulatory standards, in collaboration with the CTM;
• Ensure inspection readiness of the TMF at all times and archiving of the TMF at study completion;
• Facilitate communication with trial sites, vendors and internal team members;
• Maintain study trackers, reports and documentation systems and distribute information to stakeholders in collaboration with the CTM;
• Coordinate and schedule meetings, teleconferences, and logistics for the clinical study teams;
• Manage the request of clinical trial insurances with the insurance broker and reports on the activity to the CTM;
• Support study-specific clinical sample tracking and logistics;
• Assist with vendor coordination and follow-up activities;
• Assist in the organization of meetings, trainings and other clinical operations events;
• Adhere to company policies, SOPs and guidelines;
• Support quality control of documentation and operational processes and contribute to continuous improvement of clinical operations workflows.

Skills, Knowledge and Expertise

• Bachelor’s degree in an administrative, scientific, or business-related field, or equivalent experience.
• 5+ years of experience supporting clinical trial operations in biotech, pharma, or CRO environments.
• Working knowledge of ICH-GCP and clinical trial documentation requirements.
• Experience in coordination, tracking, and document management.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, SharePoint) and general digital tools.
• Excellent written and verbal communication skills in English.
• High attention to detail and strong follow-up skills.
• Ability to manage multiple priorities in a dynamic environment.
• Highly organized and self-driven, strong time management and prioritization skills, and collaborative team player with a proactive problem-solving mindset

Benefits

• The opportunity to develop pioneering science in a young biotech company;
• Challenging and innovative work environment as part of a driven team;
• Flexibility and ownership, based in Antwerp, Belgium, with remote working options tailored to individual needs;
• Competitive salary and benefits;
• An agile and fast paced environment.