Clinical Document Specialist II

Glaukos Corporation•Aliso Viejo, CA

About The Position

The Veeva eTMF Document Specialist is responsible for the management, quality control, and completeness of clinical trial documentation within the electronic Trial Master File (eTMF), with a focus on Veeva Vault. This role ensures that all essential documents are accurate, complete, and inspection-ready in compliance with ICH/GCP guidelines, regulatory requirements, and company SOPs. The position works cross-functionally with Clinical Operations, to support efficient trial execution and audit readiness.

Requirements

Bachelor’s degree in Life Sciences or related field preferred.
2–5+ years clinical trial or TMF experience.
Experience with Veeva Vault eTMF required.
Attention to detail
Accountability
Collaboration

Responsibilities

Management & Oversight: 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.
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.
Assist with creation of eTMF Plans and eTMF Index in partnership with Study Management.
Inspection Readiness & Compliance: 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.