Veeva CTMS and eTMF Analyst

Support:

• Incident & Problem Management
• Incident Resolution
• Applications Monitoring
• Application Break Fix
• Application & User Security Access Management
• Interface Management
• Change Management
• Configuration Management
• Documentation
• Batch Jobs (including nightly data processing)
• Data Management/Integrity
• Self Help Tools
• 3^rd Party Integration
• Regulatory Compliance
• Application Disaster Recovery
• Service Performance Management
• Job monitoring and Job Alerting
• DR Testing and Review
• Root Cause Analysis
• Proactive Maintenance
• Patches
• Quarterly & Semi-annual Maintenance
• Standard Service Types

Deviation and CAPA Management

• • • Work with Quality, Security and Compliance team to perform technical analysis for the deviation investigation(s) and capture the investigation documentation and create CAPA(s) to address documented deviations to comply with policies and procedures.
    • Work with IT, Business and Validation team for review and approval of the Deviation investigation summary and CAPA plan
    • Work with technical team/s to perform the detailed root cause analysis and identify potential solutions/configuration options as well as remediation controls
    • Create and document the technical details regarding the implementation for the Deviation/CAPA(s) and capture that information within the closure summary as required by compliance before the due date.

Change Management:

• • • Work with Quality, Security and Compliance team to document and track the Change management records for the in-scope applications
    • Work with IT, Business and Validation team for review and approval of the Change Management Tasks and Change Management closure activities.
    • Work with business to create System documentation IT Operating Procedure, IT Work Instruction and IT forms based on the new platform needs.

Release Management:

• • • Prioritization of enhancement requests
    • Technical and functional requirements
    • Development/Configuration
    • Unit testing
    • UAT coordination and support
    • Deployment of change
    • Recording evidence of change deployment (e.g., IQ execution)
    • Update change management documentation
    • Hot Fix I Emergency Release
    • Bug fix (high severity I high priority)