Study Start-Up and Regulatory Specialist - Netherlands

Job Reference: #47165 Add to saved jobs

  • Location Netherlands
  • Permanent
  • Sector Pharmaceuticals

Job Summary

Looking for a new opportunity working for an innovative global CRO? My client is currently looking for a passionate candidate to take on the role of a Study Start Up and Regulatory Specialist.  - Office based with home based flexibility - Minimal- no travel - Flexibility within the position to explore areas of interest

Job Overview

- Research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal.
- Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
- Identify site issues during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
- Support the development of start-up plans and essential document checklists.
- Responsible for contracting budget

Skills Required

- Study start-up experience
- Submissions experience
- Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Strong organizational skills
- Dutch and English

Contact Details

T: +3229824043

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