Clinical Document Specialist

1 week ago

Chennai Bengaluru Bangalore, India beBeeCompliance Full time ₹ 5,00,000 - ₹ 8,00,000
Key Responsibilities
  • Document Processing: Ensure accurate and timely document handling in line with client-specific and study-specific requirements, following SOPs/WPs and regulatory guidelines.
  • Collaboration:
  • Liaise with study teams and TMF staff to guarantee precise and punctual document processing and task completion.
  • Project Execution:
  • Complete departmental projects within established timelines while maintaining compliance with all relevant regulations.
  • File Maintenance:
  • Maintain study files according to study/client specifications, ensuring consistency and accuracy.
  • Document Management:
  • Manage document receipt and processing, including scanning, indexing, quality control, copying, filing, archiving, and reporting.
  • Reporting:
  • Provide status updates and necessary information for client and departmental reports upon request.
  • Issue Escalation:
  • Notify the Manager regarding training needs, project activities, quality concerns, timeline risks, and document requests.
  • Audit Support:
  • Participate in client and audit support as needed, assisting with document archiving.
  • Training:
  • Engage in ICON-mandated training relevant to your role and responsibilities.
  • Other Duties:
  • Perform special projects or additional tasks assigned by the Manager.
RequirementsExperience
  • 1–15 years of experience working with Trial Master File (TMF)
  • Strong understanding of clinical study documentation and GCP compliance
Skills
  • Excellent communication skills
  • Proven ability to collaborate effectively with cross-functional teams, clients, and leadership
  • Attention to detail with a focus on accuracy and regulatory compliance
Education
  • Bachelor's degree in Life Sciences (preferred)
  • Equivalent experience in clinical documentation may be considered

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