Associate Manager, Data Validation Engineer
Company: Takeda
Location: Boston
Posted on: July 13, 2025
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Job Description:
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Alien Employment Certification will be filed by Takeda Development
Center Americas, Inc. for the following job opportunity: JOB
LOCATION: Cambridge, MA POSITION : Associate Manager, Data
Validation Engineer POSITION DESCRIPTION : Takeda Development
Center Americas, Inc. is seeking an Associate Manager, Data
Validation Engineer with the following duties: provide strategic
planning, integrating, execution, build and oversight of clinical
trial deliverables. Program study level clinical data validation
checks, reconciliation listings and related data cleaning reports
adhering to internal processes, approved standards and
specifications provided by internal stakeholders. Utilize and
contribute to the development of libraries for functions and
transformation templates for reuse for study level validation
tasks. Lead validation and reconciliation efforts of collected
data, both internally and externally, by programming data
validation listings, reconciliation checks and reports in a
controlled and consistent manner. Perform data cleaning and
reconciliation and work cross-functionally with all members of
Clinical Study teams to foster an environment of quality and
efficient specifications and documentation to support
audit-readiness and ICH compliance. Coordinate maintaining, testing
and documentation of programming code and ensure compliance with
trial master file requirements. Contribute to the successful
conduct of Takeda’s clinical trials and to the delivery of
high-quality data in a timely manner, leading to statistical
analysis and submission to regulatory authorities. Work alongside
the other CDE teams to ensure adherence to Takeda standards and GCP
principles. Participate in the development of new processes and
best practices and assist with providing training and awareness to
other business groups and functions, affected by these new
activities and ways of working. Up to 100% remote work allowed.
REQUIREMENTS: Bachelor’s degree in Computer Science, Information
Technology, Statistics, Analytics, Biostatistics, Mathematics,
Biology or health-related field, plus 5 years of related
experience. Prior experience must include: (1) ensure data validity
through conformance checks and reconciling clinical study data from
various sources; (2) acquire, process, clean, integrate and store
data. Identify and communicate data issues to drive resolution;
follow applicable SOPs, WIs, and relevant regulatory guidelines
(e.g. ICH); (3) maintain well organized, complete, and up-to-date
project documentation, testing, and verification/quality control
documents and programs ensuring inspection readiness; collaborate
with data engineering and clinical product development teams; (4)
present information using data visualization techniques; maintain a
good working knowledge of clinical drug development, industry
standards, and electronic submission requirements. Full time.
$150,000 to $220,600 per year. Competitive compensation and
benefits. Qualified applicants can apply at https://jobs.takeda.com
. Please reference job R0157406. EOE Any individual may provide
documentary evidence bearing on this application, with information
on available workers and information on wages and working
conditions, to the Certifying Officer, U.S. Department of Labor,
Employment and Training Administration, Office of Foreign Labor
Certification, 200 Constitution Avenue, NW, Room N-5311,
Washington, DC 20210. Locations Boston, MA Worker Type Employee
Worker Sub-Type Regular Time Type Full time
Keywords: Takeda, Hartford , Associate Manager, Data Validation Engineer, Science, Research & Development , Boston, Connecticut
