Related skills
regulatory submissions translation tmf ich-gcp site activation📋 Description
- Deliver site activation readiness on time for assigned country/sites.
- Prepare Clinical Trial Applications and dossiers for authorities/ECs.
- Coordinate with CA/EC; update Start Up Lead and Regulatory Lead.
- Maintain project plans, trackers, and regulatory tools; support start-up plans.
- Customize country/site Patient Information Sheet and Informed Consent Form.
🎯 Requirements
- Bachelor's degree in life sciences or RN or equivalent.
- Demonstrated Regulatory or Start Up experience in CRO/pharma.
- Experience with CA/EC/IRB submissions and site activation activities.
- Strong communication, organization, and cross-functional coordination skills.
- Proficiency with computerized information systems, spreadsheets, word processing, and email.
- Fluency in English; knowledge of local clinical trial regulations is a plus.
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