Associate Director, Data Quality System Testing Expert - Leadership in cutting-edge clinical technology validation (BOSTON)
Company: Takeda Pharmaceutical
Location: Boston
Posted on: March 31, 2026
|
|
|
Job Description:
By clicking the “Apply” button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda’s Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge. Job Description 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 ACCOUNTABILITIES 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. EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS : 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.
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.
ADDITIONAL INFORMATION Requires approximately 1 - 2 domestic trips
annually and up to 1 international trip. Ability to sit and stand
for long periods of time. Carrying, handling, and reaching for
objects. Manual dexterity to operate office equipment i.e.,
computers, phones, etc. This position is currently classified as
“remote” by Takeda’s Hybrid and Remote Work policy Takeda
Compensation and Benefits Summary We understand compensation is an
important factor as you consider the next step in your career. We
are committed to equitable pay for all employees, and we strive to
be more transparent with our pay practices. For Location:
Massachusetts - Virtual U.S. Base Salary Range: $153,600.00 -
$241,340.00 The estimated salary range reflects an anticipated
range for this position. The actual base salary offered may depend
on a variety of factors, including the qualifications of the
individual applicant for the position, years of relevant
experience, specific and unique skills, level of education
attained, certifications or other professional licenses held, and
the location in which the applicant lives and/or
Keywords: Takeda Pharmaceutical, Waltham , Associate Director, Data Quality System Testing Expert - Leadership in cutting-edge clinical technology validation (BOSTON), IT / Software / Systems , Boston, Massachusetts
