Clinical Study Document Specialist

2 days ago

Delhi Mumbai Kolkata, India beBeeTMF Full time ₹ 6,00,000 - ₹ 12,00,000
Job Description:

We are seeking a detail-oriented and organized Trial Master File Specialist to join our team. The ideal candidate will have 1-15 years of experience in TMF management, with strong knowledge of clinical study documents and excellent communication skills.

As a Trial Master File Specialist, you will be responsible for:

  • Processing study documents in accordance with client and study requirements, adhering to relevant regulations and SOPs.
  • Liaising with study teams and other TMF staff to ensure effective collaboration and fulfillment of responsibilities.
  • Completing departmental projects as assigned, ensuring adherence to timelines and regulations.
  • Maintaining study files per study/client requirements and ICON SOPs/WPs.
  • Handling document receipt and processing tasks, including reviewing, scanning, indexing, and archiving.
  • Providing necessary information for client and departmental status reports as requested.
  • Informing the Manager of training issues, project activities, quality issues, and timelines.
  • Participating in audits and document archiving activities as needed.
  • Assisting in training sessions related to your responsibilities.
  • Addressing project issues with clients as directed by the Manager.
  • Undertaking special projects or additional duties as requested.
Required Skills and Qualifications:
  • Strong knowledge of clinical study documents and TMF management.
  • Excellent oral and written communication skills.
  • Ability to effectively liaise with study project teams, staff, clients, and management.
  • Bachelor's Degree in Life Sciences preferred.
Benefits:

This role offers a challenging and rewarding work environment, opportunities for professional growth and development, and a competitive compensation package.

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