Veeva Clinical SME – Techno-Functional
Remote/ MST-PST
Key Responsibilities
Provide technical and functional support for Veeva CTMS and Veeva CTMS.
Perform and review hands-on Veeva configuration, including objects, fields, workflows, lifecycles, roles, security, and study/site setup.
Support monthly enhancements and provide technical assessments before changes are promoted to Production.
Support CTMS processes such as study setup, site activation, milestones, monitoring, enrollment management, risks/issues, and study closeout.
Support Risk Management / RBQM processes and related Veeva configuration.
Support eTMF activities including EDLs, document filing, quality checks, and inspection readiness.
Support Clinical Vault security, user access, and role/permission management.
Troubleshoot Production issues, incidents, and system defects.
Support and troubleshoot EDC-to-CTMS, CRO, Payments, and other Clinical integrations.
Participate in integration design, field mapping, data flow, and error handling.
Gather business requirements and translate them into technical Veeva solutions.
Guide offshore/support teams on configuration and system best practices.
Support testing, UAT, validation, change control, deployments, and release management.
Collaborate with Clinical Operations, study teams, IT, CROs, Data Management, and other stakeholders.
Recommend opportunities for system optimization and process improvement.
Required Experience
At least 10 years of overall experience in Clinical Operations, Clinical Systems, Life Sciences IT, or a related regulated environment.
Strong hands-on experience with Veeva Vault Clinical Operations, especially CTMS and eTMF.
Several years of direct experience in a Veeva Clinical SME, techno-functional, configuration, or system support role.
Experience with Veeva configuration and administration, not only as an end user.
Strong understanding of clinical trial processes and study/site lifecycle activities.
Experience with Veeva security, roles, permissions, and user access.
Experience supporting Clinical system integrations and troubleshooting interface issues.
Familiarity with Veeva backend object models and relationships.
Experience with system testing, validation, change control, and Production support.
Ability to translate Clinical business needs into technical solutions and work independently with both business and technical teams.
Preferred
Veeva certification.
Experience with Veeva Payments.
Experience with RBQM / Risk Management.
Experience with EDC-to-CTMS and CRO integrations.
Experience supporting global clinical studies.
Key Requirement
This is a techno-functional SME role, not just a Clinical business-process role. The candidate must be comfortable with hands-on Veeva configuration, technical troubleshooting, integrations, and guiding configuration/support teams.
