Clinical Trial Document Specialist

2 days ago


Cochin, Kerala, India beBeeClinicalResearch Full time ₹ 10,00,000 - ₹ 15,00,000

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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