Senior Clinical Document Specialist

6 days ago


Dombivli, Maharashtra, India beBeeClinical Full time ₹ 15,00,000 - ₹ 25,00,000

Key Clinical Trial Documentation Expertise

  • Develop high-quality clinical trial documents, including protocols and Investigator's Brochures (IBs).
  • Translate complex scientific data into clear regulatory compliant documents for drug development and approval processes.
  • Craft abstracts and manuscripts demonstrating strong scientific communication skills.
  • Deliver accurate and well-structured documents contributing to the success of clinical research and regulatory submissions.
  • Prepare protocols, Clinical Study Reports (CSRs), Patient Information Sheets-Informed Consent Forms (PIS-ICFs) and Case Report Forms (CRFs).
  • Understand study objectives and design effective protocols.
  • Review and prepare Standard Operating Procedures (SOPs).
  • Communicate with stakeholders to ensure timely and complete documentation.


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