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Senior Clinical Research Document Specialist

3 weeks ago

Coimbatore, Tamil Nadu, India beBeeClinical Full time ₹ 7,50,000 - ₹ 15,00,000
Job Description

The ideal candidate will possess excellent writing skills and a thorough understanding of clinical trial regulations.

  • Developing Key Clinical Trial Documents:
    • Protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs)
  • Translating Complex Scientific Data:
    • Clear, regulatory compliant documents to support drug development and approval processes
  • Crafting Abstracts and Manuscripts:
    • Demonstrating strong scientific communication skills
  • Delivering High-Quality Documents:
    • Accurate, well-structured documents contributing to the success of clinical research and regulatory submissions
  • Communication with Stakeholders:
    • Ensuring effective and complete documentation within the timeline

Additional responsibilities include preparing protocols, CSRs, PIS-ICFs, and CRFs, understanding study objectives, designing protocols, preparing and reviewing SOPs, and communicating with stakeholders.


Required Skills and Qualifications

Strong writing and communication skills, excellent knowledge of clinical trial regulations, ability to translate complex scientific data into clear and regulatory-compliant documents, experience in developing key clinical trial documents, proficiency in crafting abstracts and manuscripts, and strong project management skills.


Benefits

This role offers a unique opportunity to work on exciting projects, collaborate with a talented team, and develop valuable skills in clinical research and regulatory compliance.


How to Apply

Interested candidates should submit their resume and cover letter outlining their relevant experience and qualifications for this position.