Related skills
regulatory affairs clinical trials start-up tmf ich-gcp📋 Description
- Deliver site activation readiness on time for assigned sites/country.
- Identify risks and implement mitigation plans to protect timelines.
- Prepare Clinical Trial Applications and submission dossiers for authorities.
- Interact with CA/EC for study approvals and responses.
- Maintain project plans, trackers, and regulatory tools.
- Customize Patient Information Sheet and Informed Consent Form.
🎯 Requirements
- Bachelor’s degree in life sciences or RN or equivalent.
- Pharmacy qualification or Pharmacist experience beneficial.
- Demonstrated Regulatory or Start-Up experience in CRO/pharma.
- Strong communication and organizational skills.
- Experience with computerized information systems, spreadsheets, word processing, and email.
- Fluency in English.
🎁 Benefits
- Remote-friendly work environment.
- Equal Opportunity Employer.
- Opportunities for professional growth in clinical research.
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