Lead Veeva EDC Systems Engineer @ Remote work

Ender-IT; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Ender-IT is seeking an experienced Veeva EDC specialist to provide technical and functional support across development, test, and production environments. You will configure and administer Veeva EDC, maintain studies, forms, and data-entry rules, and troubleshoot production issues to ensure timely resolution.

The role requires hands-on Veeva EDC configuration, strong knowledge of trial processes, and experience with integrations and CTMS/eTMF.

Qualifications

• Strong hands-on experience with Veeva EDC configuration and administration.
• Understanding of clinical trial processes and data management.
• Experience with integrations and APIs is desirable.
• Experience with Veeva Clinical applications such as CTMS/eTMF is a plus.
• Veeva certification or equivalent hands-on experience preferred.

Responsibilities

• Provide technical and functional support for Veeva EDC across development, testing and production environments.
• Perform hands-on Veeva EDC configuration and system administration.
• Configure and maintain studies, sites, subjects, casebooks, forms, item groups, edit checks, derivations, and data-entry rules.
• Troubleshoot production issues, incidents, integration errors, and system defects.
• Gather business and clinical requirements, assess technical impacts, and implement EDC enhancements and configuration changes.
• Support Veeva EDC integrations with CTMS, ServiceNow, safety, labs, and other clinical systems where applicable.
• Support user provisioning, role assignments, study access, and security configuration.
• Collaborate with Clinical Operations, Data Management, IT, study teams, and other cross-functional stakeholders.
• Support system testing, UAT, validation, deployments, and release management.
• Provide expert guidance on Veeva EDC best practices, platform capabilities, and clinical trial processes.
• Support study build, study amendments, mid-study changes, and production support activities.
• Assist with data review, query management, coding, and clinical data workflows where required.
• Collaborate with business stakeholders to define and prioritize the EDC enhancement and support roadmap.
• Maintain configuration documentation, change records, validation evidence, and technical documentation in accordance with GxP/CSV requirements.

Skills

Veeva EDC configuration

Veeva EDC administration

Clinical trial processes

Integrations & APIs

Veeva Certification

Tools

CTMS/eTMF

Job description

• Provide technical and functional support for Veeva EDC, including study configuration, forms, fields, rules, workflows, user access, and security.
• Perform hands-on Veeva EDC configuration and system administration across development, test, and production environments.
• Configure and maintain studies, sites, subjects, casebooks, forms, item groups, edit checks, derivations, and data-entry rules.
• Troubleshoot production issues, incidents, integration errors, and system defects, ensuring timely resolution.
• Gather business and clinical requirements, assess technical impacts, and implement EDC enhancements and configuration changes.
• Support Veeva EDC integrations, including interfaces with CTMS, ServiceNow, safety, labs, and other clinical systems where applicable.
• Support user provisioning, role assignments, study access, and security configuration.
• Collaborate with Clinical Operations, Data Management, IT, study teams, and other cross-functional stakeholders.
• Support system testing, UAT, validation, deployments, and release management.
• Provide technical recommendations and identify opportunities to improve EDC processes, usability, and automation.
• Provide expert guidance on Veeva EDC best practices, platform capabilities, and clinical trial processes.
• Support study build, study amendments, mid-study changes, and production support activities.
• Assist with data review, query management, coding, and clinical data workflows where required.
• Collaborate with business stakeholders to define and prioritize the EDC enhancement and support roadmap.
• Maintain configuration documentation, change records, validation evidence, and technical documentation in accordance with GxP/CSV requirements.

Preferred Experience:

• Strong hands-on experience with Veeva EDC configuration and administration.
• Good understanding of clinical trial processes, clinical data management, and study lifecycle activities.
• Experience with integrations and APIs is highly desirable.
• Experience with Veeva Clinical applications such as CTMS/eTMF is a plus, but not mandatory.
• Veeva certification or equivalent hands-on technical experience is preferred.