Category:
Clinical Research |
Duration: 8 Weeks / 140 Hours |
Introduction to Veeva Tools for Clinical Trial Operations
Veeva Vault Clinical Suite is one of the most widely used cloud platforms for managing clinical trial operations. It unifies Trial Master File (TMF), Clinical Trial Management (CTMS), and Study Startup (SSU) into a single system, enabling faster study execution, streamlined compliance, and perpetual inspection readiness.
The VEVA program prepares learners to understand, configure, and apply Veeva Vault tools in clinical trial operations. It blends regulatory foundations with hands-on navigation, empowering professionals to excel in sponsor and CRO environments where Veeva is the standard for digital clinical operations.
SIP – Self-Paced Online with Support
- Course Duration: 8 weeks (140 hours)
- Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
By completing this program, learners will:
- Understand the role of Veeva Vault in Clinical Trial Operations.
- Navigate Veeva Clinical applications: Vault eTMF, Vault CTMS, Vault Study Startup (SSU).
- Manage study and site documents in Vault eTMF with compliance to ICH-GCP.
- Track study milestones, monitoring visits, and action items in Vault CTMS.
- Execute study startup workflows including country/site activation in SSU.
- Apply role-based permissions and maintain audit trails for compliance.
- Ensure perpetual inspection readiness through real-time QC dashboards.
- Integrate Veeva Vault with EDC, Safety, and external sponsor systems.
- Generate reports for sponsors, CROs, and regulatory audits.
- Clinical Trial Assistants (CTAs) & Clinical Research Associates (CRAs)
- Clinical Study Managers (CSMs) using CTMS/SSU systems
- TMF Specialists managing documents in Veeva Vault eTMF
- Clinical Operations professionals at CROs and sponsors
- Career changers entering Clinical Trial Operations with system skills
- Gain hands-on exposure to Veeva Vault clinical applications.
- Build readiness for CTA, CRA, TMF Specialist, and CSM roles.
- Enhance employability in pharma, CROs, and vendor organizations.
- Be prepared for regulatory inspections and sponsor audits.
- Strengthen digital operations expertise for global clinical trials.
- Veeva Vault CTMS Specialist
- Veeva Vault eTMF Coordinator / Specialist
- Study Startup (SSU) Associate
- Clinical Trial Assistant (CTA)
- Clinical Research Associate (CRA)
- Clinical Study Manager (CSM)
- TMF Operations Manager
Modules | |
1. Introduction to Veeva Vault Clinical Suite
2. Vault eTMF – Document management and compliance workflows 3. Vault CTMS – Study, country, site, and subject tracking 4. Vault SSU – Country and site startup processes 5. Role-based permissions and audit trails (21 CFR Part 11, GDPR) 6. Site monitoring visits, trip reports, and action item tracking 7. Issue management, deviations, and CAPA workflows 8. Integration with EDC, Safety (Argus), and external sponsor systems 9. Inspection readiness and perpetual audit compliance 10. Reports, dashboards, and sponsor/CRO oversight |
For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.