Overview
Skills
Job Details
Position: Senior Business Analyst (GxP/Clinical Systems)
Location: Remote (CST hours)
Duration: Through end of year with possible extension
Job Summary:
Seeking a Senior Business Systems Consultant with strong Business Systems Analysis expertise, clinical domain experience, and GxP system knowledge to support in-flight custom development projects, system enhancements, and new capability assessments. The role requires hands-on SLC documentation, vendor coordination, and delivery of validated solutions in a regulated environment.
Must-Have:
Strong Business Systems Analysis (BSA) / BA expertise with hands-on documentation
Clinical systems or clinical trial data experience (strongly preferred)
GxP system implementation and validation expertise
Software Lifecycle (SLC) expertise (creation/review of deliverables)
Vendor management and project coordination
Experience with both Waterfall and Agile methodologies
Responsibilities:
Gather requirements and create/review SLC deliverables for clinical and GxP projects
Manage in-flight custom build and enhancement projects
Coordinate vendor activities and oversee project execution
Support pre-SLC assessments and business capability requests
Ensure compliance with GxP and successful delivery of validated systems
Provide guidance and oversight across project lifecycle activities