Clinical Systems - Build Operations Lead

Theoris•Indianapolis, IN

9d•Hybrid

About The Position

The Clinical Systems & Study Build Operations Lead will support enterprise-scale clinical trial systems, study design processes, and clinical operations initiatives within a regulated pharmaceutical environment. This role partners with clinical, technical, and operational teams to maintain critical systems, coordinate study build review and release cycles, support change management and governance processes, troubleshoot system issues, and drive process improvements that help ensure reliable and compliant clinical study execution.

Requirements

Bachelor’s degree or equivalent combination of education and relevant experience.
5+ years of experience supporting clinical systems, clinical trial technology, or clinical data management processes.
3+ years of experience managing projects, programs, governance initiatives, or process improvement efforts.
Experience working in highly regulated environments such as pharmaceutical, biotechnology, medical device, or healthcare organizations.
Experience with system troubleshooting, issue management, root cause analysis, documentation, and stakeholder communication.
Experience with clinical trial systems and tools such as EDC, CTMS, Veeva Vault CTMS, eCOA platforms, Clinical Data Management environments, Jira, Smartsheet, or similar project management tools.
Strong project management, organizational, written and verbal communication, collaboration, stakeholder management, and attention-to-detail skills.

Nice To Haves

Knowledge of Computer System Validation (CSV), Computer Software Assurance (CSA), change management, governance frameworks, controlled documentation, and clinical study build processes preferred.

Responsibilities

Support post-production change request processes, system updates, and related clinical systems workflows.
Partner with Study Build, eCOA, Clinical Data Management, analytics, and CTMS stakeholders to identify system enhancements and process improvements.
Troubleshoot user-reported issues, coordinate resolutions, escalate defects, monitor recurring issues, and support root cause analysis.
Maintain documentation of known issues, resolutions, procedures, process updates, inventories, and operational best practices.
Own the planning, coordination, and execution of study build review cycles, including timelines, release schedules, stakeholder communications, meetings, and training activities.
Support governance processes for study build automation tools, including request tracking, ownership, versioning, documentation, validation, and adoption.
Support integration activities between EDC platforms and Veeva Vault CTMS environments, including data transfer troubleshooting, testing, validation, implementation, and readiness tracking.
Provide cross-functional guidance to users across clinical systems and contribute to continuous improvement in a regulated clinical environment.