2h ago

Clinical Document Management Specialist I

Hyderabad, Telangana, India

โœจ $40k-$65k / yearest.

full-timejuniorbiotech

๐Ÿ›  Tech Stack

๐Ÿ’ผ About This Role

You'll manage the electronic Trial Master File (eTMF) for ophthalmic clinical trials, ensuring quality and compliance. Your work directly supports inspection readiness and timely documentation for study teams. Collaborate with global teams to drive continual process improvement.

๐ŸŽฏ What You'll Do

  • Manage eTMF documentation from setup through archival.
  • Perform quality-control reviews of clinical documents.
  • Generate and review metrics reports for completeness.
  • Liaise with project teams to resolve documentation issues.

๐Ÿ“‹ Requirements

  • Bachelor's degree with 1+ year in medical or research field.
  • Experience with Veeva Vault preferred.
  • Knowledge of ICH GCP and TMF Reference Model.
  • Strong attention to detail and organizational skills.

โœจ Nice to Have

  • Prior experience as Study Coordinator or Clinical Trial Associate.
  • Experience reviewing records for ALCOA+.
  • Multi-lingual communication skills.

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Recruiter Screenยท 30 min
  2. 2Hiring Manager Interviewยท 1 hour
  3. 3Team Interviewยท 1 hour
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