2h ago
Clinical Document Management Specialist II
Remote - US
โจ $70k-$95k / yearest.
full-timemid Remotehealthcare
๐ Tech Stack
๐ผ About This Role
You'll manage and oversee the electronic Trial Master File for ophthalmic clinical trials at the world's leading full-service ophthalmic drug development firm. Your work ensures compliance with SOPs and regulatory guidelines, directly supporting inspection readiness. This role offers the opportunity to become a Veeva Vault Super User and train junior team members.
๐ฏ What You'll Do
- Administer Veeva Vault document management systems
- Perform quality-control review of clinical documents
- Train team members on eTMF and documentation processes
- Assist with clinical trial close-out and archiving
๐ Requirements
- Bachelor's degree with 3 years clinical documentation experience
- 3 years experience with eTMF in clinical research
- Familiarity with ICH GCP and regulatory guidelines
โจ Nice to Have
- Experience with Veeva Vault, Montrium, or Documentum
- Prior CRO environment experience
๐ Benefits & Perks
- ๐๏ธ Remote work
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter Screenยท 30 min
- 2Hiring Manager Interviewยท 45 min
- 3Technical Interviewยท 60 min
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