eTMF Business Systems Analyst

We are seeking an experienced eTMF Business Systems Analyst to support TMF Operations and Clinical Systems & Records. The primary focus of this role will be supporting the Veeva eTMF system, including system configuration, change controls, upgrades, requirements gathering, testing, compliance, reporting, and ongoing system enhancements.

The Business Systems Analyst will work closely with business stakeholders, system owners, study teams, end users, and vendors to ensure that eTMF processes and system changes meet business, compliance, and data integrity requirements. The role will also provide support for other systems within the Clinical Systems & Records environment.

The ideal candidate will have strong experience with Veeva eTMF, business analysis, system ownership, UAT, change management, TMF metrics, and end-user support, along with excellent communication and organizational skills.

Execute complex TMF-related processes and provide oversight of documents flowing through the eTMF system.
Support the ongoing administration and business ownership of the Veeva eTMF system, including system changes, configuration, upgrades, and new releases.
Gather and document business and system requirements for eTMF enhancements and other Clinical Systems & Records initiatives.
Develop business cases and provide support for system projects, change controls, and process improvements.
Evaluate and test system changes in sandbox environments to ensure alignment with business requirements and expectations.
Develop, maintain, and execute User Acceptance Testing (UAT) scripts and document test results.
Identify and escalate change control or system issues to the appropriate Business Owner.
Coordinate with vendors on system releases, enhancements, upgrades, and related activities.
Support study and record transfer/migration activities into and out of the eTMF system.
Create and maintain eTMF reports, dashboards, job aids, Quick Reference Cards (QRCs), and other end-user reference materials.
Analyze eTMF metrics and use system dashboards and reporting tools to identify trends, gaps, and required actions.
Manage support tickets related to end-user access, document metadata corrections, and other eTMF system issues.
Ensure appropriate tracking, prioritization, routing, and resolution of system support requests.
Manage centralized and system-specific mailboxes, ensuring inquiries are promptly reviewed, triaged, and routed to the appropriate teams.
Support system compliance, data integrity, quality, and inspection-readiness activities.
Collaborate with study teams, system users, managers, business owners, and other stakeholders to resolve issues and improve TMF processes.
Support other systems within the Clinical Systems & Records portfolio as needed.
Participate in department meetings, end-user forums, and process improvement initiatives.
Perform assigned responsibilities independently while maintaining a strong focus on data quality, accuracy, and compliance.