BioSpace
Associate Manager, Data Validation Engineer
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Associate Manager, Data Validation Engineer
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BioSpace Associate Manager, Data Validation Engineer
2 weeks ago Be among the first 25 applicants Join to apply for the
Associate Manager, Data Validation Engineer
role at
BioSpace Get AI-powered advice on this job and more exclusive features. 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’sPrivacy Noticeand 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
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.
Locations Boston, MA
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Information Technology Industries Internet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Data Manager” roles.
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Join to apply for the
Associate Manager, Data Validation Engineer
role at
BioSpace Associate Manager, Data Validation Engineer
2 weeks ago Be among the first 25 applicants Join to apply for the
Associate Manager, Data Validation Engineer
role at
BioSpace Get AI-powered advice on this job and more exclusive features. 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’sPrivacy Noticeand 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
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.
Locations Boston, MA
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Information Technology Industries Internet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Data Manager” roles.
Boston, MA $60,989.00-$200,500.00 2 weeks ago Cambridge, MA $111,800.00-$175,670.00 2 days ago Associate Director, Data and Digital Enablement
Senior Manager, Enterprise Data Governance and Data Science
Associate Director, External Data Management
Data Center Manager (Data Center Operations)
Manager of Reporting & Data Visualization
Cambridge, MA $111,800.00-$175,670.00 6 days ago Newton, MA $119,000.00-$175,000.00 2 weeks ago Healthcare Compliance & Data Governance Manager
Norwood, MA $100,000.00-$130,000.00 4 weeks ago Boston, MA $68,500.00-$217,100.00 5 days ago Data and Reporting Analyst - Hardware Life Cycle Management
Quincy, MA $86,320.00-$129,480.00 2 weeks ago Sr Manager Data Governance for US Market Access Data
Medford, MA $110,000.00-$125,000.00 1 week ago Manager, Data Governance & Infrastructure
Boston, MA $170,000.00-$225,000.00 1 day ago Cambridge, MA $111,800.00-$175,670.00 1 week ago Boston, MA $102,890.67-$139,637.34 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr