Associate Director, Data Quality System Testing Expert

Job Description

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• Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in the EDC system and adherence to standards.
• Drive study database user acceptance testing activities, leading across multiple therapeutic areas and partnering closely with internal and external stakeholders to ensure the quality of the study build.
• Collaborate with vendors and cross‑functional teams to build accurate integrations.
• Ensure accurate delivery of study builds with quality deliverables per specification and participate in development, maintenance, and training around study build best practices.
• Network with key stakeholders to refine and enhance study activities, automate build processes, and reduce testing needs.
• Develop organizational knowledge of clinical data standards, key data sources, and systems, and be a valuable resource on automating study builds.
• Provide technical leadership on clinical data flow, including building APIs for data extraction and integration.
• Maintain SOPs, process maps, and templates that support operational and oversight models.
• Define and lead continuous improvement initiatives, providing strategic direction and meeting timelines, budgets, and requirements.
• Ensure data quality across databases, on‑time delivery, and quality of deliverables.
• Lead UAT activities for studies and libraries in the EDC system, including inbound integrations following an Agile approach and applicable SOPs.
• Develop UAT documentation such as Test Plans, UAT Scripts, and UAT Summary Reports.
• Create and execute standardized test scripts for EDC components, inbound integrations, and data listings.
• Record and document test results, compare to expected results, and detect software and specification failures for defect resolution.
• Lead and coordinate End User Testing activities, ensuring testers have required training and system access.
• Communicate actively with management and clinical teams about testing progress and challenges.
• Support special projects and automated testing activities, including tool identification for manual UAT script automation.
• Provide technical support, liaising with Clinical Data Engineering for troubleshooting and system issue resolution.
• Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure.
• Have experience with EDC systems such as Veeva CDMS and Rave.

• Develop, maintain, and enhance testing strategies for EDC system study/library builds and integrations.
• Coordinate and oversee end‑user testing activities, ensuring adequate training and system access.
• Generate comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports.
• Execute standardized test scripts for EDC components, inbound integrations, and data listings.
• Record and compare test results to expected outcomes and identify failures for timely defect resolution.
• Communicate testing progress, challenges, and outcomes to management and clinical teams.
• Assist in special projects and automation initiatives, identifying tools for manual UAT script automation.
• Collaborate with Clinical Data Engineering on troubleshooting and issue resolution.
• Work with cross‑functional teams and vendors to ensure accurate and efficient system integrations.
• Apply in‑depth knowledge of electronic data capture and clinical data management systems.
• Apply experience with EDC systems such as Veeva CDMS, Rave, and related technologies (eCOA, IRT, RTSM, TSDV, CDR, MDR, SCE).

• BS/BA or MS in Life Sciences, Computer Science, IT, Engineering, or a related field; approximately 10 years of experience in a CRO or pharmaceutical environment with a…