Sr. Manager, IRT User Acceptance Testing

Scorpion Therapeutics; Princeton (NJ); On-site; USD 134,000 - 163,000; Full time

Benefits offered by this job

Health benefits

Wellbeing program

Paid time off

Job summary

Scorpion Therapeutics in Princeton, NJ is seeking a seasoned QA professional to lead the QA and UAT program for IRT systems supporting clinical trials, with final responsibility for validation across concurrent projects.

You will develop test plans, mentor staff, manage UAT strategies, coordinate with the IRT team, and ensure regulatory-compliant UAT (cGMP, 21 CFR Part 11, ICH E6(R2)). Travel may be limited.

Qualifications

• BA/BS in life sciences, computer science, or MIS
• 8+ years clinical technologies validation experience (preferred IVRS/ECT)
• Strong understanding of drug development/regulatory requirements; SDLC; IRT capabilities/limitations; randomization and study drug management
• Strong project management, vendor management, communication/negotiation, analytical/influencing, problem-solving, collaboration; leadership
• Ability to evaluate complex studies and interpret potential data unblinding scenarios
• Moderate knowledge of relationship databases; strong Word/Excel literacy

Responsibilities

• Develop test plans and test strategies for assigned IRT projects.
• Assist with UAT quality assurance strategy (standards, processes, procedures, methodologies, practices).
• Mentor new hires; train internal/external personnel on UAT process and methodology.
• Manage UAT approaches, documentation, acceptance criteria, UAT structure, and executed test assets.
• Coordinate UAT plans with the IRT team; review/approve test deliverables.
• Review/provide feedback on user requirements; report quality metrics.
• Analyze vendor/internal observations and propose objectives; ensure infrastructure for quality initiatives.
• Collaborate with and support vendor activities; independently resolve issues as they develop.
• Ensure timely and regulatory-compliant UAT (cGMP, 21 CFR Part 11, ICH E6 (R2)) per SOPs.
• Engage/support study and project teams as needed; may develop processes/standards.
• Limited travel may be required.

Skills

QA testing experience

SDLC knowledge

Vendor management

Project leadership

Regulatory awareness

Education

BA/BS in life sciences, computer science, or MIS

Job description

Position Summary

This role develops and implements the Quality Assurance (QA) and User Acceptance program for IRT systems supporting clinical trials, with final responsibility for QA and testing activities for assigned projects, including validation across multiple concurrent projects.

Position Responsibilities

• Develop test plans and test strategies for assigned IRT projects.
• Assist with UAT quality assurance strategy (standards, processes, procedures, methodologies, practices).
• Mentor new hires; train internal/external personnel on UAT process and methodology.
• Manage UAT approaches, documentation, acceptance criteria, UAT structure, and executed test assets.
• Coordinate UAT plans with the IRT team; review/approve test deliverables.
• Review/provide feedback on user requirements; report quality metrics.
• Analyze vendor/internal observations and propose objectives; ensure infrastructure for quality initiatives.
• Collaborate with and support vendor activities; independently resolve issues as they develop.
• Ensure timely and regulatory-compliant UAT (cGMP, 21 CFR Part 11, ICH E6 (R2)) per SOPs.
• Engage/support study and project teams as needed; may develop processes/standards.
• Limited travel may be required.

Experience Requirements (Qualifications/Skills)

• BA/BS in life sciences, computer science, or Management Information.
• 8+ years clinical technologies validation experience (preferred IVRS/electronic clinical supplies distribution).
• Strong understanding of drug development/regulatory requirements; SDLC; IRT capabilities/limitations; randomization and study drug management.
• Strong project management, vendor management, communication/negotiation, analytical/influencing, problem-solving, collaboration; leadership.
• Ability to evaluate complex studies and interpret potential data unblinding scenarios.
• Moderate knowledge of relationship databases; strong Word/Excel literacy.

Compensation/Benefits

Princeton, NJ: $134,170–$162,586 starting range; additional incentive opportunities may be available.

• Health, wellbeing, and financial protection benefits; paid time off (flexible time off or vacation/holidays by location).