Clinical Document Specialist

3 days ago


Jodhpur, Rajasthan, India beBeeDocument Full time ₹ 60,00,000 - ₹ 1,20,00,000

Job Title:

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Clinical Research Associate is responsible for authoring and analyzing clinical trial documents. This involves working with key clinical documents such as Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan, and more.

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  • Author and analyze clinical trial documents to ensure accuracy and compliance.
  • Create, validate, and refine prompts for AI-assisted document generation to improve efficiency and quality.
  • Apply knowledge of clinical trial phases, study design, and drug development to support the success of clinical trials.
  • Maintain compliance with global regulatory standards including FDA, EMA, and ICH-GCP regulations.
  • Utilize medical terminologies and ontologies for clarity and consistency in clinical trial documentation.
  • Ensure quality control and timely delivery of assigned tasks to meet project deadlines.
  • Collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.
  • Provide regular updates and flag risks to the project manager to ensure effective communication and decision-making.
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What We Offer:

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  • Opportunity to work on a variety of projects with major firms in banking, healthcare, telecom, and media.
  • Chance to develop skills and expertise in clinical research and document management.


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