Clinical Document Specialist I

1 month ago


Pune, Maharashtra, India TransPerfect Full time
About the Role

We are seeking a highly detail-oriented and organized Clinical Document Specialist I to join our team at TransPerfect. As a Clinical Document Specialist I, you will play a critical role in reviewing and managing essential and non-essential TMF documents for assigned projects.

Key Responsibilities
  • Review documents in eTMF workflow to complete initial indexing and ensure accurate filing.
  • Sustain and improve quality thresholds, meeting daily productivity goals as defined in organization SOPs.
  • Identify challenges and suggest solutions, communicating efficiently with stakeholders.
  • Keep study-specific trackers up to date and communicate them to Project Managers.
  • Coordinate with Clinical Document Team Leads for project-related queries and maintain project documentation.
  • Assist with User Acceptance Testing during product development and release.
Requirements
  • Knowledge of clinical development phases and processes, including GCP and ICH regulations.
  • Understanding of essential documents and clinical study documentation.
  • Superior written and spoken communication skills in English.
  • Proficiency in Microsoft Office (Word, Excel, Outlook) and knowledge of eClinical technologies.
Qualifications and Experience
  • Minimum bachelor's degree or its equivalent.
  • Up to 1 year of experience in the Life Sciences industry.

This is a fantastic opportunity to join a dynamic team and contribute to the success of our Clinical Document Services team at TransPerfect.



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