phenox GmbH is a specialized manufacturer of Class III medical devices for the treatment of neurovascular diseases, which are developed, manufactured and distributed. Our innovative technologies and solutions are used by neuroradiologists worldwide to treat strokes and aneurysms. We offer a growing portfolio of innovative treatment options - including long-established technologies.

To enlarge our clinical programs team we are looking as soon as possible for a

Global Clinical Study Coordinator (m/f/d) hybrid, full-time

Your job duties

Support of the coordination and administration of global clinical studies
Prepare study specific procedures and tools
Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements
Responsible for maintaining TMF “inspection readiness”
Responsible for final study archiving
Support in CTA Management & Site payments
Support submissions to ethic committees or competent authorities
Ensure compliance with all relevant regulatory requirements/rules imposed by the authorities (GDPR, GCP, MDR, ISO14155, FDA e.g.)

your profile

University / College degree (life sciences, health sciences, information technology or related subjects preferred) or training as a medical documentalist or study nurse, or other equivalent experience
2 years’ experience in the field of clinical research and clinical studies
Knowledge of ICH, GCP, ISO 14155, MDR, good documentation practice, knowledge of FDA regulation is an advantage
Very good English (written and spoken)
Flexible approach to work & problem solving attitude
Work independently and yet be a great team player, ability to work in a hybrid team
Microsoft Office (Word, Excel, PowerPoint, Outlook, Visio etc.)

We Offer

an international & dynamic team
flexible working environment
a comprehensive on-boarding
possibility to evolve within the team
a fair and motivating remuneration system
pension scheme
company events/company celebrations
flat rate for drinks
JobRad

Does this appeal to you?

Then please send your complete documents, including the earliest possible starting date and your salary expectations, exclusively as a PDF file by e-mail to:

bewerbung@wallabyphenox.com

Job Types: Full Time

Locations: Europe

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