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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Veeva Vault eTMF system administration, governance, and lifecycle management while ensuring compliance with regulatory requirements and industry standards. Proficient in developing testing strategies, training materials, and optimizing TMF processes through AI-enabled capabilities.
Highest-signal resume keywords
Veeva Vault eTMF AdministrationETMF Systems ExpertiseAI-Enabled TMF CapabilitiesUser Acceptance Testing (UAT)Regulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Lifecycle ManagementDocument TransfersData MigrationsAutomated Document ClassificationMetadata PopulationQuality ChecksWorkflow OptimizationTesting StrategiesDefect ManagementAudit Trail Reviews
Soft Skills
Stakeholder CommunicationChange ManagementTraining DevelopmentGovernance Facilitation
Industry Keywords
TMF ProcessesLife SciencesClinical Development OperationsTMF Reference ModelQuality RequirementsData IntegrityRisk AssessmentsCorrective Actions
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Own and administer the Veeva Vault eTMF system
- Lead governance, configuration oversight, lifecycle management, enhancements, requirements prioritization, and release planning
- Partner with technology teams and vendors to resolve system issues and implement improvements
- Oversee integrations, data migrations, archival activities, and document transfers
- Ensure compliance with regulatory requirements, company procedures, industry standards, and quality requirements
- Evaluate, implement, and expand AI-enabled TMF capabilities
- Drive automated document classification, metadata population, quality checks, and workflow optimization initiatives
- Define AI use cases, requirements, success metrics, and feedback loops; monitor AI performance
- Evaluate emerging technologies and industry trends
- Lead UAT and business validation for Veeva Vault releases and enhancements
- Develop testing strategies, scripts, execution plans, and defect management processes
- Coordinate stakeholder testing and deployment readiness
- Support validation documentation and change control activities
- Support TMF process design, optimization, standardization, quality, completeness, timeliness, and inspection readiness
- Develop and maintain procedures, job aids, training materials, and best practices
- Monitor compliance and data integrity; conduct audit trail reviews, risk assessments, and trend analyses
- Support audits and inspections; investigate deviations and implement corrective and preventive actions
- Develop and deliver training for system users and stakeholders
- Provide consultation and support to study teams, TMF Operations, and external customers
- Lead communication and change management for new capabilities
- Facilitate governance meetings and report on system performance, priorities, risks, and innovation initiatives
Requirements
What you’ll need- Serve as the primary business owner and SME for Veeva Vault eTMF
- Experience and expertise in eTMF systems, TMF processes, and life sciences clinical development operations
- Knowledge of system governance, configuration oversight, lifecycle management, integrations, data migrations, archival activities, and document transfers
- Experience evaluating and implementing AI-enabled TMF capabilities
- Knowledge of automated document classification, metadata population, quality checks, and workflow optimization
- Experience with User Acceptance Testing (UAT), business validation, testing strategies, test scripts, execution plans, and defect management
- Knowledge of TMF Reference Model updates, TMF standards, and metadata governance
- Knowledge of regulatory requirements, company procedures, industry standards, quality requirements, compliance, data integrity, audit trails, risk assessments, and corrective and preventive actions
- Experience developing system procedures, job aids, training materials, and best practices
- Equivalent experience, skills, and/or education will also be considered
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate