Lead Clinical Document Specialist

4 days ago

Jamnagar, Gujarat, India beBeeClinical Full time ₹ 17,56,250 - ₹ 21,52,500
Clinical Research Associate Job Description

About our organization:

We specialize in digital engineering and IT services, helping clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation. We partner with major firms in banking, healthcare, telecom, and media.

Key Responsibilities of Clinical Document Authoring:

  • 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.
  • 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.
Required Skills and Qualifications:

To succeed in this role, you will need:

  1. A deep understanding of clinical trials, including phases, study design, and drug development.
  2. Excellent communication and analytical skills.
  3. The ability to work collaboratively in a team environment.
  4. Proficiency in medical terminologies and ontologies.
Benefits:

This is an excellent opportunity to join our team and take your career to the next level. You will have the chance to work on exciting projects, develop new skills, and contribute to the growth and success of our organization.

Others:

Please note that we are committed to providing a positive and inclusive work environment. We offer competitive compensation and benefits packages, as well as opportunities for professional development and growth.

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