Site Start up EUCTR II/ Initiation Clinical Research Associate II
Core
Planning and submitting complex EUCTR submissions for large Phase II and III trials across multiple countries and sites.
Role type
Site Start Up Clinical Research Associate
Builds
Regulatory submissions for clinical trials
Domain
Clinical drug development / Regulatory affairs
Deliverable
client delivery
Required skills
Vendor management, Trial management systems (CTMS, TMF), Project management, Cross-functional team interaction, ICH/GCP/EUCTR/IVDR regulatory knowledge, Study start-up experience
Preferred skills
Leadership, Data-driven planning, Strategic direction implementation
Technologies
CTMS, TMF, MS Project, PowerPoint, Word, Excel
Responsibilities
Plan and submit complex EUCTR submissions, Implement operational strategic direction for clinical studies, Manage study team collaborations, Manage vendors
Seniority
Mid-level, hands-on IC
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