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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 platform administration and maintenance, with a strong focus on eTMF processes and GxP compliance. Proficient in gathering business requirements, translating them into functional specifications, and executing testing activities, including User Acceptance Testing.
Highest-signal resume keywords
Veeva Vault eTMFGxP ComplianceComputerized System Validation (CSV)User Acceptance Testing (UAT)Clinical Operations
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Veeva Vault eTMFComputerized System Validation (CSV)User Acceptance Testing (UAT)Business Requirements GatheringFunctional SpecificationsChange Control ManagementSystem Lifecycle ManagementTesting CoordinationETMF ProcessesClinical Research Knowledge
Soft Skills
Strong CommunicationStakeholder ManagementCollaborationTraining SkillsAnalytical Skills
Industry Keywords
GxP-Regulated SettingsClinical OperationsChange ControlSystem EnhancementsGlobal Cross-Functional Teams
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Support the administration, maintenance, and continuous improvement of the Veeva Vault eTMF platform
- Serve as a functional point of contact for eTMF and Clinical Operations stakeholders
- Gather, analyze, and translate business requirements into functional specifications and user stories
- Support system enhancements, releases, and implementation of new functionalities
- Prepare and execute testing activities, including User Acceptance Testing (UAT), and manage issue resolution
- Contribute to Computerized System Validation (CSV), change control, and GxP compliance activities
- Provide user support and training
- Collaborate with Clinical Operations, Quality, IT, and global teams
Requirements
What you’ll need- Hands-on experience with Veeva Vault eTMF and a strong understanding of eTMF processes
- Solid knowledge of Clinical Operations within a clinical research environment
- Experience working with computerized systems in GxP-regulated settings
- Good understanding of Computerized System Validation (CSV) principles and activities
- Experience managing system changes, change controls, and system lifecycle activities
- Ability to gather business requirements and translate them into functional specifications and User Stories
- Experience preparing, executing, and coordinating testing activities, including UAT
- Strong communication and stakeholder management skills, with experience working in global cross-functional teams
- Fluent in English
Benefits
Comp & perks- Opportunity to work at Excelya, a leading mid-size CRO and one-stop healthcare provider
- Diverse projects across full-service, functional service provider, and consulting models
- Collaboration with preeminent experts
- Employee experience focused on natural talents, personal growth, and potential
- Inclusive environment fostering collaboration and individual growth