Senior Clinical Document Specialist

Summary

Join Vaxcyte, a clinical-stage vaccine innovation company, as a Senior Clinical Document Specialist! This role supports the electronic Trial Master File (eTMF) team, collaborating with internal and external contributors. Key responsibilities include performing quality control in Veeva Vault eTMF, managing the TMF support mailbox, contributing to TMF plans and indices, and supporting global TMF health activities. You will also develop training materials and participate in system change control. The ideal candidate possesses a BA/BS in life sciences with 8+ years of pharmaceutical/biotechnology experience and Veeva Vault eTMF expertise. This position offers a competitive compensation package, including comprehensive benefits and an equity component.

Requirements

• BA/BS degree in life sciences with a minimum of 8 years of experience in the pharmaceutical or biotechnology industry
• Must have industry experience managing or supporting TMF initiatives, preferably in a Sponsor or CRO environment
• Veeva Vault eTMF experience is required
• Strong communication skills and the ability to collaborate across teams
• Flexible and adaptable to a fast-paced, dynamic environment
• Excellent time management and organizational skills
• Proficient with Microsoft Office Suite and SharePoint
• Familiarity with clinical trial documentation and regulatory requirements across all phases of drug development

Responsibilities

• Perform Quality Control (QC) activities within Veeva Vault eTMF in compliance with established processes
• Serve as a member of the TMF Operations team, managing the TMF support mailbox, triaging TMF-related inquiries, and assigning tasks to appropriate team members
• Contribute to the development of study-specific TMF Plans and TMF Indices, ensuring alignment across departments
• Support global TMF health activities, including generating and analyzing TMF metrics, identifying trends, and escalating issues as necessary
• Participate in system change control activities, such as User Acceptance Testing (UAT), to support system updates and improvements
• Develop and maintain training materials, Quick Reference Guides, Standard Operating Procedures (SOPs), and Work Instructions (WIs) to ensure consistency and clarity in TMF processes
• Assist in the delivery of high-quality eTMF system training and documentation for team members and stakeholders
• Drive process improvement initiatives for TMF operations to enhance efficiency and compliance
• Act as an eTMF subject matter expert (SME) during audits and provide support for audit responses
• Collaborate on training programs to address process gaps and enhance team proficiency in eTMF operations
• Support other TMF-related responsibilities and projects as required

Benefits

• Competitive compensation package
• Comprehensive benefits
• Equity component
• Salary Range: $112,000 – $131,000 (SF Bay Area)
• Open to remote