Takeda · 2 weeks ago
Associate Director, Data Quality System Testing Expert
United States
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
10+ years expTakeda is a leading global pharmaceutical company committed to bringing better health and a brighter future to patients. The Associate Director, Data Quality System Testing Expert will create and execute test plans and UAT scripts to ensure the quality of study builds in the EDC system, collaborating with various stakeholders and leading user acceptance testing activities.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase