Senior Clinical Trial Associate - Remote Flexible Ownership

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

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.