Clinical Trial Assistant

Cochlear; Antwerpen; Sur place; EUR 32 000 - 45 000; Plein temps

Avantages offerts par ce poste

Flexible working arrangements

Résumé du poste

Cochlear in Belgium is seeking a highly organised Clinical Trial Assistant for a one-year fixed-term role within the Clinical Operations team.

You will provide essential administrative support for international clinical trials, coordinating with CPMs, CRAs, sites and partners across Europe and globally to ensure compliant and efficient study execution.

Qualifications

• Bachelor's degree in Health Sciences, Biomedical Sciences, Nursing, Pharmacy, Life Sciences, or a related discipline.
• Excellent organisational and administrative skills with attention to detail.
• Strong proficiency in Microsoft Office and web-based applications.
• Excellent communication skills with diverse stakeholders.
• Ability to manage multiple priorities and work independently or in a team.
• Professional fluency in English.

Responsabilités

• Support Purchase Order creation and track site and trial payments.
• Assist CPMs and CRAs with ISF creation and maintenance.
• Support Ethics Committee submissions and site communications.
• Track trial documentation and coordinate data collection from sites.
• Ensure activities comply with Cochlear SOPs, GCP, and ISO 14155.
• Maintain CTMS and electronic Trial Master File records.

Connaissances

Organisational skills

Administrative skills

Communication skills

Microsoft Office

English fluency

Formation

Bachelor's degree in Health Sciences or related

Outils

CTMS

eTMF

Description du poste

We are looking for a highly organised and proactive Clinical Trial Assistant (CTA) for a one year Fixed term role to join our Clinical Operations team in Belgium.

In this role, you will provide essential administrative support for the planning, execution, and documentation of international clinical trials that contribute to the development of life-changing hearing solutions.

Working closely with Clinical Project Managers (CPMs), Clinical Research Associates (CRAs), clinical sites, and external partners, you will help ensure studies are conducted efficiently, accurately, and in compliance with regulatory requirements and industry standards.

The Opportunity

As Clinical Trial Assistant, you will play a key role in supporting clinical research activities throughout the study lifecycle. You will coordinate and file documentation, organize trial payments, perform clinical systems administration, and study tracking activities while collaborating with colleagues and stakeholders across Europe and globally.

This is an excellent opportunity for someone looking to build or further develop a career in clinical research within a leading global medical device company.

Key Responsibilities

Clinical Operations Support

• Support supplier budget administration through the creation of Purchase Orders (POs) and the tracking of site and clinical trial payments.
  


• Assist Clinical Project Managers and Clinical Research Associates with the creation and maintenance of Investigational Site Files (ISFs).
  


• Support the preparation and tracking of Ethics Committee submissions and site communications.
  


• Track essential clinical trial documentation and assist with document collection from investigational sites.
  


• Ensure all activities are conducted in accordance with Cochlear SOPs, Good Clinical Practice (GCP), and ISO 14155 requirements.
  

Trial Documentation & Quality Management

• Maintain the electronic Trial Master File (eTMF), including document filing, naming, classification, and quality review activities.
  


• Perform document quality checks and identify missing or incomplete documentation.
  


• Support study startup, maintenance, and close-out documentation activities.
  

Clinical Systems Support

• Assist with maintaining study information within the Clinical Trial Management System (CTMS).
  


• Provide administrative support across clinical systems and databases used to manage clinical studies.
  


• Ensure accurate and timely updates of clinical trial records.
  


• Partner with local and global Clinical Operations teams and external stakeholders.
  


• Contribute to process improvement initiatives and operational excellence projects.
  


• Support additional administrative and project activities as required.
  

About You

Essential Requirements

• Bachelor's degree in Health Sciences, Biomedical Sciences, Nursing, Pharmacy, Pharmacology, Life Sciences, or a related discipline.
  


• Excellent organisational and administrative skills with strong attention to detail.
  


• Strong proficiency in Microsoft Office and web-based applications.
  


• Excellent communication skills with the ability to engage effectively with diverse stakeholders.
  


• Ability to manage multiple priorities and work both independently and within a team environment.
  


• Professional fluency in English.
  

Preferred Experience

• Previous experience in clinical research, healthcare administration, the medical device industry, pharmaceuticals, or a related environment.
  


• Knowledge of Good Clinical Practice (GCP) and ISO 14155 guidelines.
  


• Experience with eTMF, CTMS, or other clinical trial management systems.
  


• Experience working in an international and matrixed organisation.
  

Why Join Cochlear?

We offer in this role:

• The opportunity to contribute to life-changing medical technologies.
  


• A collaborative and inclusive international environment.
  


• Career development and learning opportunities.
  


• Exposure to global clinical research programs.
  


• Flexible working arrangements.
  


• A supportive culture focused on wellbeing, quality, and continuous improvement.
  

Ready to Make a Difference?

If you're passionate about clinical research, organisation, and improving patient outcomes through innovative healthcare solutions, we'd love to hear from you.