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Job Description
Clinical Document Specialist II Glaukos - 3.8 Aliso Viejo, CA Job Details Full-time $73,600 - $92,000 a year 19 hours ago Qualifications Performance dashboard reports Document control within pharmaceutical industry Filing Metrics Reporting Mid-level Reporting and dashboarding tools Quality control audit ICH guidelines Bachelor's degree Regulatory readiness in healthcare Clinical research inspection readiness Clinical quality assurance standards Metadata Training Cross-functional collaboration Standard operating procedures (SOPs) 2 years Content review Cross-functional communication Audit support Research compliance quality assurance records management
Full Job Description How You'll Contribute:
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.
What You'll Do:
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.
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 #GKOSUS Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases. Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients. Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts. Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.
