2h ago
Clinical Document Management Specialist I
Hyderabad, Telangana, India
โจ $40k-$65k / yearest.
full-timejuniorbiotech
๐ Tech Stack
๐ผ 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.
๐ฏ 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.
๐ 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.
โจ Nice to Have
- Prior experience as Study Coordinator or Clinical Trial Associate.
- Experience reviewing records for ALCOA+.
- Multi-lingual communication skills.
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter Screenยท 30 min
- 2Hiring Manager Interviewยท 1 hour
- 3Team Interviewยท 1 hour
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