- Location
- BE Mechelen, Belgium
- Type
- Full-time
- Department
- Healthcare
- Education
- Bachelor
- Source
- Workday
Description
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
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?
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.
Apply now and help us bring the gift of hearing to more people around the world.
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
This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
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.