Documents Specialist Ii

Precision Medicine Group

Bangalore, India
On-site
Document qc and indexing in etmf
Knowledge of ich-gcp guidelines
Experience with tmf close-out activities
The Documents Specialist II is responsible for preparing TMF plans and ensuring document quality control in accordance with GCP and regulatory guidelines

Job Summary

  • The Documents Specialist II is responsible for preparing TMF plans and ensuring document quality control in accordance with GCP and regulatory guidelines.
  • This role involves monitoring document submissions to prevent backlogs and managing the complete close-out activities for assigned clinical studies.
  • Candidates must demonstrate a working knowledge of ICH-GCP, relevant SOPs, and possess strong self-motivation to handle complex data ecosystems.

Matching Summary

The Documents Specialist II is responsible for preparing TMF plans and ensuring document quality control in accordance with GCP and regulatory guidelines.

Skills & Requirements

Must-have

  • Document QC and indexing in eTMF
  • Knowledge of ICH-GCP guidelines
  • Experience with TMF close-out activities
  • Proficiency in Microsoft Office Suite

Nice-to-have

  • Strong interpersonal communication skills
  • Ability to work independently and in teams
  • Detail-oriented approach to data management

Key Requirements

  • 4-year college degree or equivalent
  • Minimum 5 years of clinical trial experience
  • Minimum 3 years of TMF/eTMF experience
  • Fluency in English at professional level

Work Rights

Not specified

Tailored Resume

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