Associate Director, Data Quality System Testing Expert

Role Summary

Associate Director, Data Quality System Testing Expert responsible for leading UAT and test planning for EDC study/library builds, collaborating with cross-functional teams and vendors to ensure data quality and accurate integrations. Develop and maintain test artifacts, drive automation opportunities, and provide technical leadership on clinical data flow and system testing within a regulated CRO/pharmaceutical environment. Lead End User Testing activities, mentor testers, and communicate testing progress to management and clinical teams.

Responsibilities

• Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in EDC systems and adherence to standards.
• Drive study database user acceptance testing activities with leadership across multiple therapeutic areas, partnering with internal and external stakeholders to ensure quality of the study build in the EDC system.
• Collaborate with vendors and cross-functional teams to ensure accuracy of integrations and data flows.
• Develop, maintain, and train on activities around study build and best practices; refine activities to automate study build and reduce testing requirements.
• Develop organizational knowledge of clinical data standards, data sources, and systems; provide guidance on automating study builds to pursue company objectives; provide technical leadership on API build and data integration.
• Maintain SOPs, process maps, templates, and timelines to support operational oversight.
• Lead functional Continuous Improvement initiatives with strategic direction and deliverables aligned to timelines and budgets.
• Ensure data quality across databases and timely delivery of data deliverables; oversee UAT for studies and libraries in EDC with Agile approaches per SOPs.
• Develop UAT documentation (Test Plans, UAT Scripts, UAT Summary Reports) and standardized test scripts for EDC components, inbound integrations, and data listings.
• Record and document test results, compare to expected results, and identify defects for timely resolution.
• Coordinate End User Testing activities; ensure testers are trained and have system access; communicate testing progress and challenges with management and clinical teams.
• Support special projects and automated testing activities, including tool identification for manual UAT script automation.
• Provide technical support, liaising with Clinical Data Engineering (CDE) for troubleshooting and issue resolution; collaborate with cross-functional teams and vendors to ensure integration accuracy.
• Demonstrate strong understanding of electronic data capture and clinical data management systems (EDC/CDM) and related infrastructure, with experience in systems such as Veeva CDM, Rave, and related technologies.

Qualifications

• Required: BS/BA or MS in Life Science, Computer Science, IT, Engineering, or related field with about 10 years of CRO/pharmaceutical experience; proven and consistent record of proactive management and innovation.
• Required: Experience with EDC and clinical data management systems; familiarity with clinical research technologies (eCOA, IRT, RTSM); software testing and quality assurance experience.
• Required: Proficiency in Agile methodologies and adherence to SOPs; strong problem-solving skills and attention to detail.
• Preferred: Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders; track record of leading and delivering complex business transformation programs.
• Required: Understanding of clinical data management processes and regulations.

Education

• BS/BA or MS in Life Science, Computer Science, IT, Engineering, or related field.

Additional Requirements

• Requires approximately 1 - 2 domestic trips annually and up to 1 international trip.
• Ability to sit and stand for long periods; carrying, handling, and reaching for objects; manual dexterity for office equipment.