Bachelor's degree in life sciences, computer science, information systems, or related field (or equivalent experience).
Hands-on business analysis experience with Veeva Vault Clinical (eTMF, CTMS, SSU) implementations or enhancements.
Strong knowledge of clinical trial processes, including site startup, monitoring, and TMF management.
Proven skills in requirements gathering, process mapping, functional specifications, and UAT in a GxP-validated environment.
Working knowledge of the Vault data model, lifecycles, security roles, and reporting tools; familiarity with VQL and integrations.
Experience with Jira, Confluence, ServiceNow, or similar ALM tools.
Excellent stakeholder management and communication skills.
Veeva Vault certification and CBAP/PMI-PBA preferred.
Responsibilities
Partner with clinical operations and stakeholders to gather and prioritize requirements for Vault Clinical.
Translate business needs into user stories and functional specifications; recommend process changes based on fit-gap analyses.
Facilitate requirements workshops and maintain a traceability matrix throughout the project lifecycle.
Author and execute test scripts, coordinating user acceptance testing and tracking defects.
Assess the impact of Veeva releases on processes and communicate changes to stakeholders.
Define reporting needs and validate Vault Reports and Dashboards for key performance indicators.
Support data migration and integration requirements, including field mapping and validation.
Benefits
401k match
Comprehensive group health, dental, and vision benefits
Life insurance and long-term disability
Discretionary PTO
Full Job Description
Role Overview & Responsibilities
Partner with clinical operations, data management, regulatory, and site management stakeholders to elicit and prioritize requirements for Vault Clinical (eTMF, CTMS, SSU).
Translate business needs into user stories, process flows, and functional specifications; run fit-gap analyses against standard Vault functionality and recommend process or configuration changes.
Facilitate requirements workshops and design sessions; maintain a requirements traceability matrix from build through test and release.
Author and execute test scripts, coordinate UAT with business users, and track defects through resolution and sign-off.
Assess the impact of Veeva tri-annual releases on processes and configuration, define regression scope, and communicate changes to stakeholders.
Define reporting needs and KPIs (TMF completeness, site activation, monitoring) and validate Vault Reports and Dashboards.
Support data migration and integration requirements, including field mapping and validation of loaded data.
Produce SOPs, work instructions, and training materials; support end-user training, change management, and adoption.
Support backlog and release planning in Agile or hybrid delivery, ensuring documentation aligns with GCP, ICH, 21 CFR Part 11, and CSV expectations.
Vault Clinical Business Analyst - Skills & Qualifications
Bachelor's degree in life sciences, computer science, information systems, or a related field (or equivalent experience).
Hands-on business analysis experience on Veeva Vault Clinical (eTMF, CTMS, and/or SSU) implementations or enhancements.
Strong knowledge of clinical trial processes, including site startup, monitoring, and TMF management (TMF Reference Model).
Proven skill in requirements gathering, process mapping (e.g., BPMN, Visio), functional specifications, and UAT in a GxP-validated environment.
Working knowledge of the Vault data model, lifecycles, security roles, and Vault Reports and Dashboards; familiarity with VQL, Vault Loader, and integrations.
Experience with Jira, Confluence, ServiceNow, or similar ALM and ticketing tools.
Excellent stakeholder management, facilitation, and communication skills.
Veeva Vault certification (e.g., Vault Platform Fundamentals, eTMF, or CTMS) and CBAP/PMI-PBA preferred.
Veeva Vault Administrator - Role Overview & Responsibilities
Serve as the primary Vault administrator for Clinical Operations, supporting configuration, maintenance, and continuous improvement across eTMF, CTMS, and SSU.
Partner with clinical operations, regulatory, site management, and IT teams to turn business requirements into scalable Vault configurations.
Handle day-to-day administration: user provisioning, security management, object configuration, and document and object lifecycles, workflows, and expected document logic.
Configure and maintain study/site/country hierarchies, milestone tracking, document taxonomies, and completeness metrics to support site activation, investigator document collection, monitoring, TMF completeness, and regulatory submissions.
Manage external access for sites, CROs, and investigators, including portal settings and sharing rules.
Participate in Veeva tri-annual releases: assess upgrade impact, coordinate UAT with business stakeholders, and implement configuration changes.
Provide Tier 1 and Tier 2 functional support, triaging and resolving issues and escalating to Veeva Support as needed.
Maintain system documentation (configuration specs, SOPs, training guides, release notes) and support audit readiness and data integrity reviews in line with GCP and regulatory requirements.
Veeva Vault Administrator - Platform, Technical Skills and Qualifications
Bachelor's degree in life sciences, computer science, information systems, or a related field (or equivalent experience).
General Vault Platform administration experience across other Vault applications, such as Quality (QMS, QualityDocs), in addition to Clinical Operations.
Hands-on configuration experience in at least two of eTMF, CTMS, and SSU, with a strong understanding of site startup, monitoring, TMF management, and country/site regulatory document workflows.
Configure objects, fields, picklists, relationships, page layouts, and lifecycles (states, transitions, entry criteria, workflow actions) using the Admin UI and VPK migration packages.
Manage the Vault security model: application roles, permission sets, atomic security, sharing settings, and dynamic access control (DAC); support SSO, authentication policies, and periodic access recertification.
Build Vault Reports and Dashboards for operational and compliance metrics, and write VQL queries for data extraction, document audits, and ad-hoc reporting.
Use Vault Loader and CSV imports for bulk data operations; manage FTP/SFTP integrations and automated document ingestion; working knowledge of Vault integrations.
Apply sandbox-to-production deployment and configuration migration best practices.
Proficiency in requirements gathering, functional specifications, test scripts, and training documentation.
Experience in a CRO, life sciences consulting, or sponsor environment supporting multiple concurrent programs; familiarity with ServiceNow and ALM tools.
Benefits
401k match
Comprehensive group health, dental, vision benefits
