Clinical Trial Assistant

C50 Cochlear Benelux NV (Belgium); Mechelen; Sur place; EUR 32 000 - 46 000; Plein temps

Résumé du poste

Cochlear is seeking a highly organized Clinical Trial Assistant (CTA) for a one-year fixed-term role in Belgium. You will support international clinical trials, coordinate documentation, and ensure compliance with GCP and ISO 14155.

The role collaborates with CPMs, CRAs, sites, and partners across Europe and globally. The position emphasizes trial documentation, budget tracking, study startups, and quality management, with opportunities to grow in clinical research within a leading medical

Qualifications

• 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.

Responsabilités

• Clinical Operations Support – Support supplier budget administration through the creation of Purchase Orders (POs) and the tracking of site and clinical trial payments.
• Trial Documentation & Quality Management – Maintain the electronic Trial Master File (eTMF), including document filing and quality checks.
• Clinical Systems Support – Assist with maintaining study information within the CTMS and other clinical systems.
• Collaboration & Continuous Improvement – Partner with local/global Clinical Operations teams and external stakeholders and support process improvements.

Connaissances

Organisational skills

Administrative skills

Communication skills

Multitasking

English proficiency

Formation

Bachelor's degree (Health/Science)

Outils

Microsoft Office

Web-based applications

Description du poste

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market‑leader in implantable hearing devices, more people choose a Cochlear‑branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

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.
• Collaboration & Continuous Improvement – 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

• 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?

At Cochlear, you'll be part of an organisation that combines innovation, purpose, and collaboration. 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.

What we offer

• An attractive remuneration package and flexible extra‑legal benefits
• An extensive onboarding and training program
• An enjoyable work environment with attention to life‑work balance and homeworking
• A stimulating environment with growth opportunities and opportunity to meet multi‑disciplinary colleagues across the globe

Cochlear Summary

Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear‑branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).

Equal opportunities

Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion/belief or age. In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect - this is an important aspect of ensuring equal opportunities in employment.

Our growth is creating great opportunities! Our team is expanding and we want to hire the most talented people we can. Continued success depends on it. So once you've had a chance to explore our current open positions, apply to the ones you feel suit you best and keep track of both your progress in the selection process, and new postings that might interest you! We're the global leader in implantable hearing solutions. We have provided more than 600,000 implantable devices, helping people of all ages to lead full and active lives. We help people hear and be heard. We empower people to connect with others and live a full life. We help transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes.