Associate Director, Data Quality System Testing Expert

Takeda

22h•Remote

About The Position

OBJECTIVES/PURPOSE Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in EDC system and adherence to standards. Drive study database user acceptance testing activities in a role that requires leadership across multiple therapeutic areas and the ability to partner closely with internal/external stakeholders to ensure the quality of the study build in the EDC system. Collaborate with various vendors and cross functional teams to build to ensure accuracy of any integration. Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business. Network with key business stakeholders on refining and enhancing the activities around study to automate the study build and reduce the need for testing. Develop organizational knowledge of organizational clinical data standards, key data sources, systems and be a valuable resource to people in the company on how to effectively automate study build to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including build APIs to various systems for data extraction and integration. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. Defines and/or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements. Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data deliverables. Lead UAT activities for studies and libraries in EDC system, including inbound integrations with an Agile Approach according to applicable SOPs (standard operating procedures) and processes. Develop UAT documentation such as Test Plans, UAT Scripts, UAT Summary Report and etc. Create and execute standardized test scripts for EDC components, inbound integrations, and data listings. Record and document test results and compare to expected results. Detect software and specifications failures, so that defects may be discovered and corrected. Lead and coordinate End User Testing Activities, ensure that End User 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 CDE for troubleshooting and system 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, clinical databases, data flow, and related infrastructure, with experience in/around EDC systems such as Veeva CDM

Requirements

BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field or analytical area with ~10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of 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.

Nice To Haves

Previous 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 organizational culture change as well as delivering on programs with complex business deliverables.

Responsibilities

Test Plan and Script Execution: Create and execute detailed test plans and User Acceptance Testing (UAT) scripts, ensuring alignment with business requirements and technical specifications. Validate study/library functionality within EDC systems and confirm adherence to established standards.
Testing Strategy Development: Develop and enhance testing strategies for EDC system study/library builds and integrations.
Stakeholder Collaboration: Network with key stakeholders to refine and improve study build automation and testing reduction strategies.
Leadership in UAT Activities: Lead UAT for studies and libraries, including inbound integrations, using an Agile approach and in accordance with SOPs and processes. Coordinate and oversee End User Testing activities, ensuring testers are adequately trained and have necessary system access.
UAT Documentation Development: Develop comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports.
Standardized Test Script Creation: Develop and execute standardized test scripts for EDC components, inbound integrations, and data listings.
Testing Results Analysis: Record and document test results, comparing them to expected outcomes. Identify software and specification failures for timely defect resolution.
Communication and Reporting: Actively communicate with management and clinical teams about testing progress, challenges, and outcomes.
Support for Special Projects: Assist in special projects and automated testing initiatives, including the identification of tools for manual UAT script automation.
Technical Support and Troubleshooting: Provide technical support, collaborating with Clinical Data Engineering (CDE) for system troubleshooing and issue resolution.
Cross-functional Collaboration: Work closely with cross-functional teams and vendors to ensure accuracy and efficiency in system integrations.
Expertise in Clinical Data Systems: Demonstrate in-depth knowledge of electronic data capture, clinical data management systems, and related infrastructure. Utilize experience with various EDC systems (e.g., Veeva CDMS, Rave) and related clinical research technologies (e.g., eCOA, IRT, RTSM).S and Rave, Veeva CDB, elluminate® Data Central, EHR, eCOA, IRT, RTSM, TSDV, CDR, MDR, SCE and adjacent systems.