Senior Clinical Documentation Specialist

2 days ago


Anand, Gujarat, India beBeeClinicalResearchAssociate Full time ₹ 15,00,000 - ₹ 25,00,000
Clinical Research Associate

About the Role:

We are seeking a skilled Clinical Research Associate to join our organization. In this position, you will be responsible for creating and analyzing clinical trial documents.

Key Responsibilities:

  • Create 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.
  • Develop, 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 (FDA, EMA, ICH-GCP).
  • 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.
  • Provide regular updates and flag risks to the project manager.

The ideal candidate will have 1-5 years of experience in a similar role and any graduation degree. They should be proficient in working with flexible schedules and possess excellent communication skills.



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