Senior Clinical Documentation Specialist

1 day ago


Vijayawada, Andhra Pradesh, India beBeeClinical Full time ₹ 15,00,000 - ₹ 24,15,000

About Us:

We are a leading provider of digital engineering and IT services.

Our expertise combines deep industry knowledge with agile development practices, enabling scalable and cost-effective solutions for our clients.

Job Title: Clinical Document Author

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:

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

Benefits:

  • Experience: 1 -5 Years
  • Education Qualification: Any Graduation
  • Work Mode: Hybrid
  • Employment Type: Contract
  • Notice Period: Immediate - 15 Days
  • Interview Mode: 2 Rounds of Technical Interview

Others:

We encourage interested candidates to submit their CVs for consideration.



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