Related skills
negotiation regulatory affairs clinical trials ich-gcp site contracts📋 Description
- Deliver site activation readiness on time.
- Prepare Clinical Trial Application forms and submission dossiers for CA/EC.
- Interact with CA/EC and respond to submissions.
- Maintain project plans, trackers, and regulatory tools.
- Develop start-up plans and essential document review criteria.
- Collaborate with site CRA to align communication.
🎯 Requirements
- Bachelor's degree in life sciences or RN, or equivalent.
- 1+ year regulatory or site start-up experience in CRO/pharma.
- Strong communication and organizational skills.
- Experience with electronic systems, spreadsheets, and email.
- English fluency; local language for base country.
- Preferred: milestone tracking tools experience.
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