Veeva CTMS and eTMF Analyst

The TMF and CTMS Analyst is responsible for performing the following activities:

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

3rd 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

System Sustainment Services:

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