Senior Clinical Trial Associate

Agomab; Antwerpen; Hybride; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Flexibility & ownership

Antwerp location & remote options

Competitive salary

Challenging environment

Résumé du poste

Agomab Antwerp is seeking a Senior Clinical Trial Associate to provide high-quality administrative and operational support to the Clinical Operations Team. You will maintain study documentation, support TMF, ensure inspection readiness, and collaborate with CTMs, vendors and study teams in line with ICH-GCP and SOPs.

The role requires strong organization, attention to detail, and the ability to manage multiple priorities in a fast-paced biotech environment.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Clinical ops experience

Attention to detail

English communication

Time management

Proactive problem-solving

Formation

Bachelor’s degree in administrative/scientific/business fields

Outils

Microsoft Office

SharePoint

Description du poste

Description

The Senior Clinical Trial Associate (CTA) is providing high-quality administrative and operational support to the Clinical Operations Team. In this role, you will report to the Head of Clinical Operations. You will play a critical part in ensuring the efficient, compliant, and timely execution of our clinical trials. The CTA is responsible for maintaining study documentation, supporting trial logistics, and ensuring inspection readiness while working closely with Clinical Trial Managers (CTMs), vendors, and study teams. The role requires strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced biotech environment. All activities are conducted in compliance with ICH-GCP, company SOPs, and applicable regulatory requirements.

Department: Clinical Development

Location: Agomab Antwerp

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

Who are you?

• 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.