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

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