Senior Business Analyst (GxP/Clinical Systems)

Overview

Remote
Depends on Experience
Contract - W2
Contract - Independent
Contract - 12 Month(s)

Skills

Business Analysis
Clinical Trials
Regulatory Compliance
Project Lifecycle Management
Vendor Management
Waterfall
GxP

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

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