Associate Director, Data Quality System Testing Expert

Role Summary

Associate Director, Data Quality System Testing Expert overseeing the planning, execution, and leadership of UAT testing for EDC systems and study/library builds. Leads cross-functional testing activities, collaborates with vendors and internal teams, and drives continuous improvement in testing strategies and data quality across studies.

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.
• Lead study database user acceptance testing activities across multiple therapeutic areas and partner with internal/external stakeholders to ensure study build quality in the EDC system.
• Collaborate with vendors and cross-functional teams to ensure integration accuracy.
• Ensure accurate delivery of study builds with quality deliverables per specification; participate in development, maintenance, and training related to study build and best practices.
• Engage stakeholders to refine and automate study build and reduce testing needs.
• Develop organizational knowledge of clinical data standards, data sources, and systems; provide guidance on automating study build to meet company objectives; provide technical leadership on clinical data flow and APIs for data extraction and integration.
• Maintain SOPs, process maps, templates, and timelines to support operational oversight.
• Lead functional Continuous Improvement initiatives aligned with timelines and budgets.
• Coordinate cross-functional activities to ensure data quality and on-time delivery of data deliverables.
• Lead UAT activities for studies and libraries in EDC, including inbound integrations, using an Agile approach per SOPs and processes.
• 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 expectations, and identify defects for resolution.
• Lead and coordinate End User Testing activities, ensuring testers have required training and system access.
• Communicate testing progress and challenges to 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 with experience in EDC systems (e.g., Veeva CDM, Rave) and related technologies.

Qualifications

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

Skills

• Electronic Data Capture (EDC) systems and clinical data management
• Veeva CDMS, Rave, eCOA, IRT, RTSM, and related clinical research technologies
• Test planning, UAT script creation, and defect management
• Agile methodologies and SOP-driven processes
• Cross-functional collaboration and vendor management
• Technical leadership in data flow and API integration

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 to operate office equipment.
• Remote work classification per company policy; location: Massachusetts – Virtual.