Related skills
clinical trials start-up regulatory tmf ca_ec📋 Description
- Ensure site activation readiness for assigned country/sites.
- Prepare Clinical Trial Applications and submission dossiers.
- Interact with CA/EC for study submissions and responses.
- Maintain project plans, trackers and regulatory tools.
- Customize country/site-specific Patient Information Sheet and Informed Consent Form.
- Review and manage documents for site activation and IMP release.
🎯 Requirements
- Bachelor’s degree in life sciences or RN or equivalent.
- 1+ year as Regulatory or Start-Up specialist in CRO/pharma.
- Strong communication and organizational skills.
- Experience with CA/EC submissions and regulatory timelines.
- Fluency in English.
- Advanced degree in medical/life sciences or RAC preferred.
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