Clinical Data Management QA & Validation Analyst

Merck & Co.; Rahway (NJ); Hybrid; USD 72,000 - 113,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co. in Rahway, NJ, seeks an Associate Clinical Data Management Analyst to support testing and validation of clinical data management systems used in trials. The role works within SDLC guidelines, SOPs, and ICH-GCP standards to ensure data integrity.

You will assist with QC/UAT procedures, validate EDC and related systems, and help maintain test documentation while collaborating with cross-functional teams to deliver compliant solutions.

Qualifications

• Bachelor's degree in Mathematics, Computer Science, Life Sciences, Health Care, Information Systems, or related discipline.
• Familiarity with SDLC and system validation.

Responsibilities

• Support QC testing and UAT procedures for clinical data management systems.
• Participate in testing/validation of EDC, electronic diaries, IVRS/IWRS, and other data management technologies.
• Create, review, and maintain test documentation (plans, scripts, traceability matrices).
• Collaborate with CDM, Programming, Standards, and technical teams to implement test requirements.
• Review database configurations, edit checks, reports, and data transfers.
• Identify, document, and communicate testing issues; support resolutions.
• Contribute to project deliverables while ensuring regulatory compliance.
• Develop knowledge of CDM processes, trial systems, and validation methodologies.
• Engage in departmental initiatives and continuous improvement.

Skills

SDLC knowledge

Attention to detail

Communication skills

Analytical thinking

Team collaboration

Microsoft Office

Education

Bachelor's degree

Tools

SQL

Python

EDC systems

Job description

Merck & Co. in Rahway, NJ, seeks an Associate Clinical Data Management Analyst to support testing and validation of clinical data management systems used in trials. The role works within SDLC guidelines, SOPs, and ICH-GCP standards to ensure data integrity.

You will assist with QC/UAT procedures, validate EDC and related systems, and help maintain test documentation while collaborating with cross-functional teams to deliver compliant solutions.