Clinical Trial Assistant

Cochlear Limited; Antwerpen; Hybride; EUR 42 000 - 64 000; Plein temps

Avantages offerts par ce poste

Flexible working arrangements

Onboarding and training program

Life-work balance and homeworking

Global and collaborative environment

Résumé du poste

Cochlear Limited in Mechelen, Belgium is seeking a highly organized Clinical Trial Assistant for a one-year fixed-term role within the Clinical Operations team. You will support planning, execution and documentation of international clinical trials, coordinating with CPMs, CRAs, sites and external partners to ensure compliant, efficient study conduct.

The ideal candidate holds a Health Sciences degree, demonstrates strong organizational skills, and is fluent in English, with experience in or

Qualifications

• Bachelor's degree in Health Sciences or related discipline.
• Excellent organizational and administrative skills with strong attention to detail.
• Professional fluency in English and strong communication abilities.
• Experience or familiarity with GCP/ISO guidelines is a plus.

Responsabilités

• Provide essential administrative support for planning, execution and documentation of international clinical trials.
• Support ISF preparation, ethics submissions, trial payments and CTMS/eTMF updates.
• Coordinate with CPMs, CRAs, sites and external partners to ensure regulatory compliance.
• Assist with document control, quality checks and study startup/close-out activities.

Formation

Bachelor's degree in Health Sciences

Outils

eTMF

CTMS

Description du poste

## Clinical Trial AssistantApply: Mechelen, Belgium: Full time: Posted Today: R-623976Change 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 Assistan**t, 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 benefitsAn extensive onboarding and training programAn enjoyable work environment with attention to life-work balance and homeworkingA stimulating environment with growth opportunities and opportunity to meet multi-disciplinary colleagues across the globeThis 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!