
Clinical Trial Document Specialist
2 days ago
About Our Company:
We are a global IT services company that specializes in digital engineering and IT services.
Our company partners with major firms in banking, healthcare, telecom, and media.
Key Responsibilities:
- Author and analyze clinical trial documents.
- Work with key clinical documents: Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan and more.
- Create, validate, and refine prompts for AI-assisted document generation.
- Apply knowledge of clinical trial phases, study design, and drug development.
- Maintain compliance with global regulatory standards.
- Utilize medical terminologies and ontologies for clarity and consistency.
- Ensure quality control and timely delivery of assigned tasks.
- Collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.
Familiarity with FDA, EMA, ICH-GCP is required.
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