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Clinical Operations / Veeva Vault

Brittany Walker

Principal Consultant

Brittany Walker helps life sciences sponsors and CROs run clinical operations and Veeva Vault programs that hold up under inspection, from study start-up and site operations through cross-vault administration, custom configuration, and Veeva release management. She works fluently across the Veeva Clinical, Quality, and Regulatory suites, anchored in ICH GCP and 21 CFR Part 11.

Study start-up & site operations

Supports sponsors and CROs through trial start-up and site-side execution, including site activation workflows, investigator site file management, site communications, and operational discipline that holds up under GCP inspection.

Cross-vault Veeva administration

Custom configuration, health checks, and integration design across the Veeva Clinical, Quality, and Regulatory suites. Surfaces configuration debt and missed optimization, and keeps cross-vault Connectors aligned.

TMF, ISF, and inspection readiness

Drives TMF and ISF completeness against industry reference standards. Translates ICH GCP E6(R3) and 21 CFR Part 11 expectations into operating controls regulators recognize.

Brittany Walker, Principal Consultant at USDM Life Sciences
Clinical operations
Study start-up
TMF & ISF readiness
Cross-vault Veeva
Veeva configuration & health checks
Veeva release management
Sponsor & CRO support
ICH GCP

Brittany Walker's Credentials

Brittany helps clinical teams keep documentation and Vault operations from becoming inspection-week panic material.

Her work pairs clinical process discipline with the platform-level controls sponsors and CROs need for TMF and ISF completeness, cross-vault governance, sponsor-CRO collaboration, and Vault operations that are ready for what's next.

Proof points

Principal Consultant at USDM Life Sciences

Certified Veeva Vault Platform Administrator

Cross-vault Veeva experience across Clinical (eTMF, CTMS, Site Connect, Study Training, SLD), Quality, and Regulatory suites

Custom configuration and Veeva health check delivery, including configuration debt, security gaps, and value-realization opportunities

Veeva release management across multiple sponsor and CRO environments

Clinical program and project management across sponsor, CRO, vendor, and IT coordination

Contributor to CDISC industry-standards work on the TMF Standard Model and ISF Reference Model

Where she helps

Clinical operations and cross-vault Vault execution

Support for sponsors and CROs across the study lifecycle: study start-up, site operations, TMF and ISF readiness, sponsor-CRO collaboration, and Vault administration across Clinical, Quality, and Regulatory. Includes custom configuration, integration design, security harmonization, Veeva release management, and AI readiness assessments to position Vault content for AI-enabled workflows.

How Brittany helps clients solve it

Stand up study start-up workflows aligned to ICH GCP E6(R3) and sponsor or CRO SOPs
Assess TMF and ISF completeness against industry reference standards
Manage research site operations and communications across investigator sites and CROs
Build and optimize cross-vault Veeva configurations, including health checks that surface configuration debt and missed value
Run Veeva release impact assessments and coordinate validation with Cloud Assurance
Design sponsor-CRO collaboration frameworks: performance metrics, data quality reviews, transition planning, and CRO readiness for sponsor oversight
Conduct AI readiness assessments to prepare Vault content, metadata, and workflows for AI-enabled operations

Contact Brittany Walker

Start a conversation about clinical operations, cross-vault Veeva execution, or Vault health checks before the next inspection turns into a treasure hunt.

Use the form to route a conversation about clinical operations, study start-up, sponsor-CRO collaboration, TMF and ISF readiness, cross-vault Veeva configuration and health checks, Veeva release management, or AI enablement.

Contact Brittany Walker

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