Clinical Data Systems Testing Specialist

JD: Clinical Data Systems Testing Specialist

Objective / Purpose:

The Clinical Data Systems Testing team ensures that clinical data platforms function reliably and meet quality and regulatory expectations. This role supports that mission by leading User Acceptance Testing (UAT) activities and facilitating end user testing (EUT) for clinical data systems such as EDC, IRT, and eCOA, helping to deliver accurate, compliant, and inspection-ready study builds. Accountabilities:

• Lead system user acceptance testing and facilitate end user acceptance testing activities to
• ensure the quality of the study build in the EDC, IRT, and eCOA systems.
• Lead UAT activities for the standards library including developing and executing
• detailed test plans, UAT scripts, and UAT Summary Reports.
• Lead requirements gathering and testing for system upgrades and data pipeline projects,
• completing associated documentation, where applicable.
• Create and execute detailed test plans, UAT scripts, and UAT Summary Reports, etc in Excel
• and /or ALM testing system based on business requirements and technical specifications to
• verify database functionality (e.g. EDC, IRT, eCOA) and adherence to standards.
• Record and document test results, comparing them to expected outcomes and identifying
• software and specification failures for timely defect resolution. •
• Assist in special projects and automated testing initiatives, as applicable.
• Collaborate with cross-functional teams and vendors to ensure integration accuracy.
• Communicate actively with management and clinical teams about testing progress and challenges.

Education & Competencies (Technical and Behavioral):

Education & Core Experience: BS/BA in life science, computer science/IT, engineering, or related analytical field;

7+ years in CRO/pharma using EDC and clinical data systems.

• EDC/CDM Domain Expertise: Strong understanding of EDC/CDM systems, clinical databases, data flow, and supporting infrastructure. • Platform & Ecosystem Exposure: Experience in/around systems such as Veeva CDMS, Rave, Veeva CDB, Elluminate / Data Central, EHR, eCOA, IRT, RTSM, and adjacent systems.

• Testing, Validation & QA: Software testing and quality assurance experience; functional expertise in testing and validation of clinical systems.

• Industry & Regulatory/Submissions Understanding: Solid understanding of pharma/clinical development and technology regulations and requirements supporting EDC and clinical data systems.

• Ways of Working: Strong communication and project management skills.