Related skills
project management cross-functional leadership regulatory submissions irb ec📋 Description
- Drive country/regional site start-up activities and strategy
- Manage core/site document collection and approvals
- Lead ICF customization and IRB/EC submissions
- Ensure timely IMP release package delivery
- SME for in-country RSSs/CRAs/PSSs on start-up topics
- Develop country-specific tools and guidance for site start-up
🎯 Requirements
- Bachelor's degree in life sciences or RN, or equivalent
- 3+ years in start-up, ideally SU Lead/PM in CRO/pharma/biotech
- 1+ year milestone management, budgeting, and resource coordination
- 1+ year experience presenting to clients
- Fluent in English; local language as applicable
- Demonstrated leadership and cross-functional collaboration
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