Related skills
contract negotiation regulatory submissions ich-gcp good clinical practice site start-up📋 Description
- Deliver site activation readiness in assigned country/sites.
- Prepare Clinical Trial Applications and submission dossiers for CA/EC.
- Interact with CA/EC for study submissions and responses.
- Provide updates about CA/EC submissions to Start Up Lead and Project Manager.
- Maintain project plans, trackers and regulatory intelligence tools.
- Coordinate country/site start-up documents and translations.
🎯 Requirements
- Bachelor's degree in life sciences or RN or equivalent.
- 3.5+ years as Regulatory or Site Start-Up specialist.
- English proficiency (professional level).
- Knowledge of GCP/ICH Guidelines.
- Excellent communication and organizational skills.
- Ability to work independently in a fast-paced environment.
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