Senior Clinical Document Specialist - Remote

Overview

Vaxcyte is looking for an energetic and talented individual to join Vaxcyte as a Senior Clinical Document Specialist within the Regulatory department, supporting the electronic Trial Master File (eTMF) team for all products in development.

In Short

• Perform Quality Control (QC) activities within Veeva Vault eTMF.
• Manage the TMF support mailbox and triage TMF-related inquiries.
• Contribute to the development of study-specific TMF Plans and TMF Indices.
• Support global TMF health activities and analyze TMF metrics.
• Participate in User Acceptance Testing (UAT) for system updates.
• Develop and maintain training materials and Standard Operating Procedures (SOPs).
• Assist in delivering eTMF system training and documentation.
• Drive process improvement initiatives for TMF operations.
• Act as an eTMF subject matter expert during audits.
• Support other TMF-related responsibilities and projects.

Requirements

• BA/BS degree in life sciences with a minimum of 8 years of experience.
• Experience managing or supporting TMF initiatives in a Sponsor or CRO environment.
• Veeva Vault eTMF experience is required.
• Strong communication skills and ability to collaborate across teams.
• Flexible and adaptable to a fast-paced environment.
• Excellent time management and organizational skills.
• Proficient with Microsoft Office Suite and SharePoint.
• Familiarity with clinical trial documentation and regulatory requirements.

Benefits

• Opportunity to work in a mission-driven company.
• Collaborative and inclusive work environment.
• Engagement in innovative vaccine development.
• Professional growth and development opportunities.