Clinical Documentation Specialist

1 day ago


Amrāvati, Maharashtra, India beBeeClinicalDocumentation Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Clinical Documentation Specialist

We are seeking a highly skilled Clinical Documentation Specialist to join our team. This is an exciting opportunity to leverage your expertise in clinical trial documentation and scientific communication.

  • Develop high-quality key clinical trial documents, including protocols, investigator brochures, informed consent forms, case report forms, and clinical study reports.
  • Translate complex scientific data into clear, regulatory compliant documents that support drug development and approval processes.
  • Craft abstracts and manuscripts, demonstrating strong scientific communication skills.
  • Prioritize delivering high-quality, accurate, and well-structured documents that contribute to the success of clinical research and regulatory submissions.
  • Collaborate with stakeholders to ensure effective and complete documentation within timelines.

Main Responsibilities:

  • Prepare and review protocols, CSRs, PIS-ICFs, and CRFs.
  • Design protocols aligned with study objectives.
  • Develop and maintain SOPs.

Skill Requirements:

  • Expertise in developing clinical trial documents.
  • Strong scientific writing and communication skills.
  • Ability to work independently and as part of a team.
  • Attention to detail and ability to meet deadlines.

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