Associate Manager, Data Validation Engineer

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for 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.

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