Lead UAT Manager – Clinical Trial Tech & Validation

Clinical Supply Consulting; Malvern (Chester County); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Generous paid time off

401(k) with company match

Friendly, smart, passionate coworkers

Opportunities for professional growth

Job summary

Clinical Supply Consulting is seeking a Manager, UAT Services to lead UAT activities for clinical trial tech platforms (IRT, eCOA, and related systems). You will partner with sponsors, CROs, vendors, and internal experts to craft risk-based test strategies, execute tests, and deliver audit-ready documentation.

You will develop plans and scripts, translate requirements into test scenarios, manage defects, and coordinate projects with multi-stakeholder teams.

Qualifications

• Bachelor's degree or equivalent experience required.
• 7+ years of experience in clinical research or related fields.
• Experience developing or executing test scripts and validation documents.
• Strong organizational and project coordination abilities.
• Excellent communication and stakeholder management.
• Proficiency with Microsoft Excel, Word, and Teams.
• Experience with IRT, RTSM, eCOA, EDC, CTMS, eConsent or related systems.
• Experience supporting UAT, validation, or system implementations.
• Knowledge of GCP, GxP, FDA Part 11, and CSV principles.
• Experience working with sponsors, CROs, or software vendors.
• Consulting or client-facing background.

Responsibilities

• Develop, review, and maintain UAT plans, test scripts, traceability matrices, and summary reports.
• Analyze system requirements and translate them into risk-based test scenarios.
• Support UAT execution, defect management, and issue tracking activities.
• Coordinate project deliverables, timelines, reviews, and stakeholder feedback.
• Serve as a day-to-day contact for sponsor and vendor teams during UAT activities.
• Ensure testing documentation is complete, accurate, and inspection-ready.
• Support process improvement initiatives and expansion into new clinical technology platforms.
• Participate in client meetings, project planning discussions, and capabilities presentations as needed.

Skills

7+ years in clinical research/testing

Test script development & validation

Project coordination & organization

Communication & stakeholder management

UAT/validation project experience

GCP/GxP/FDA Part 11 knowledge

Sponsor/CRO/vendor engagement

Consulting/client-facing experience

Education

Bachelor's degree or equivalent experience

Tools

Microsoft Excel

Microsoft Word

Microsoft Teams

Job description

Clinical Supply Consulting is seeking a Manager, UAT Services to lead UAT activities for clinical trial tech platforms (IRT, eCOA, and related systems). You will partner with sponsors, CROs, vendors, and internal experts to craft risk-based test strategies, execute tests, and deliver audit-ready documentation.

You will develop plans and scripts, translate requirements into test scenarios, manage defects, and coordinate projects with multi-stakeholder teams.