Research Document Specialist

6 days ago

Alleppey, Kerala, India beBeeClinical Full time ₹ 14,00,000 - ₹ 20,95,000
Job Title:

Clinical Research Associate

">Job Description:">
  • 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 (FDA, EMA, ICH-GCP).">
  • 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.">
  • Provide regular updates and flag risks to the project manager.">

Required Skills and Qualifications:">

Skills required for this position include Protocol , Informed Consent Form (ICF) , FDA , EMA , ICH-GCP.

">

Experience 1 -5 Years is necessary for this role. Education qualification Any Graduation is preferred.

">

Work Mode Hybrid. Employment Type Contract. Notice Period Immediate - 15 Days.

">Benefits:">

This role offers a great opportunity for career growth and professional development.

">

The company operates in over 50 locations across more than 25 countries, providing opportunities for collaboration and innovation.

">

Others:">

Interview mode 2 Rounds of Technical Interview.

">

Interested candidates please apply by sharing your CV to sushma.n@people-prime.com

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