Study Documents Coordinator

7 days ago


Kolkata Delhi Mumbai, India beBeeDocumentation Full time ₹ 6,00,000 - ₹ 12,00,000
Job Summary

We are seeking a skilled and experienced TMF Specialist to join our team. The ideal candidate will have a strong background in clinical study documents, excellent communication skills, and the ability to effectively liaise with project teams, staff, clients, and management.

Key Responsibilities:
  • Process study documents in line with client requirements and adhere to ICON SOPs/WPs and relevant regulations.
  • Liaise with study teams and other TMF staff to fulfill responsibilities effectively.
  • Complete departmental projects as assigned, ensuring adherence to timelines and regulations.
  • Maintain study files per study/client requirements and ICON SOPs/WPs.
  • Handle document receipt and processing tasks, including reviewing, scanning, indexing, and archiving.
  • Provide necessary information for client and departmental status reports as requested.
  • Inform the Manager of training issues, project activities, quality issues, and timelines.
  • Participate in audits and document archiving activities as needed.
  • Assist in training sessions related to your responsibilities.
  • Address project issues with clients as directed by the Manager.
Qualifications and Skills:
  • 1-15 years of experience in TMF (Trial Master File) with a strong knowledge of clinical study documents.
  • Ability to effectively communicate with study project teams, staff, clients, and management.
  • Excellent oral and written communication skills.
  • Bachelor's Degree in Life Sciences preferred.


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