Clinical Data Management QA Analyst

Merck; New Jersey; On-site; USD 72,000 - 113,000; Full time

Job summary

Merck is seeking an Associate Clinical Data Management Analyst to support testing and validation of clinical data management systems used in trials. This role ensures compliance with SDLC, SOPs and ICH-GCP guidelines.

You will contribute to test plans, execute QC/UAT, validate EDC and related tools, document test evidence, and collaborate across Clinical Data Management, Programming and Standards to ensure quality and regulatory readiness.

Qualifications

• Basic understanding of SDLC and system validation.
• Strong attention to detail and quality focus.
• Good written and verbal communication skills.
• Strong organizational, analytical, and problem-solving abilities.
• Ability to work independently and with cross-functional teams.

Responsibilities

• Support creation and execution of QC testing and UAT procedures for clinical data management systems.
• Participate in testing/validation of EDC, electronic diaries, IVRS/IWRS, and related tools.
• Assist with test documentation: plans, scripts, traceability matrices, evidence.
• Collaborate with Clinical Data Management, Programming, Standards, and technical teams to implement test requirements.
• Review and verify database configurations, edit checks, reports, data transfers, and functionality.
• Identify, document, and communicate testing issues and resolutions.
• Contribute to SDLC-compliant project deliverables and regulatory alignment.
• Develop knowledge of clinical data management processes, systems, and validation methods.
• Participate in departmental initiatives and continuous improvement.

Skills

SDLC knowledge

Attention to detail

Communication skills

Analytical skills

Organizational skills

Independent work

Education

B.A./B.S. degree in Math/CS/Life Sciences/Health Care/IS

Tools

SQL

Python

Automation tools

Generative AI

Job description

Merck is seeking an Associate Clinical Data Management Analyst to support testing and validation of clinical data management systems used in trials. This role ensures compliance with SDLC, SOPs and ICH-GCP guidelines.

You will contribute to test plans, execute QC/UAT, validate EDC and related tools, document test evidence, and collaborate across Clinical Data Management, Programming and Standards to ensure quality and regulatory readiness.