Clinical Document Specialist

5 days ago

Kurnool, Andhra Pradesh, India beBeeClinical Full time ₹ 60,00,000 - ₹ 1,00,00,000
Job Description

As a clinical document authoring professional, you will be responsible for creating and analyzing clinical trial documents. You will work with key clinical documents such as protocols, informed consent forms, and clinical study reports.

You will apply your knowledge of clinical trial phases, study design, and drug development to create high-quality documents. You will also ensure compliance with global regulatory standards (FDA, EMA, ICH-GCP) and utilize medical terminologies and ontologies for clarity and consistency.

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 (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
Required Skills and Qualifications

Skills:

  • Protocol
  • Informed Consent Form (ICF)
  • FDA
  • EMA
  • ICH-GCP
Benefits

Hybrid work mode and contract employment type make this role attractive to professionals seeking flexibility.

Others

Interested candidates please share their CV to a designated email address.

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