Related skills
project management cross-functional leadership regulatory affairs irb ec📋 Description
- Drive country/regional site start-up activities.
- Execute the site start-up strategy and planning.
- Coordinate Core/Site document collection and approvals.
- IRB/EC submissions and IMP release packaging.
- Act as SME for questions by in-country RSSs, CRAs, PSSs and others.
- Develop country-specific tools and guidance documents for start-up.
🎯 Requirements
- Bachelor's degree in life sciences or RN or equivalent.
- 3+ years in startup, SU Lead or PM in CRO or biotech.
- 1+ year milestone management, resource and budget coordination.
- 1+ year client presentation experience.
- Demonstrated cross-functional leadership.
- Fluency in English and the local language where the position is based.
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