Clinical Document Specialist II
Glaukos Corporation · Aliso Viejo, CA · 1 wk ago
AdministrativeFull-time
How You’ll Contribute
- Maintain the eTMF within Veeva Vault, ensuring all documents are filed accurately and in the correct structure.
- Perform ongoing TMF quality reviews (completeness, timeliness, accuracy, and consistency) in partnership with Study Management.
- Track document status and follow up with study teams to resolve gaps.
What You’ll Do
- Document Processing & Quality Control - Review clinical documents for quality, metadata accuracy, and regulatory compliance prior to filing.
- Ensure documents meet ALCOA+ principles.
- Perform QC checks on documents uploaded by internal teams.
- Audit & Inspection Readiness - Support audit and inspection readiness activities.
- Generate TMF reports, metrics, and dashboards.
- Identify trends and escalate compliance risks.
- Cross-Functional Collaboration - Partner with Clinical Trial Assistants, CRAs, Study Managers, Data Management and Biostatics.
- Provide guidance and training to study teams.
- Collaborate with Study Teams to ensure TMF alignment.
How You’ll Get There
- Bachelor’s degree in Life Sciences or related field preferred.
- 2–5+ years clinical trial or TMF experience.
- Experience with Veeva Vault eTMF required.
- Key Competencies - Attention to detail, Accountability, Collaboration