Senior Manager, Clinical Data Configuration Engineer - Takeda
Cambridge, MA 02138
About the Job
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 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 DescriptionKey to Takeda’s success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables
The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis. The Clinical Data Sciences comprises of the Clinical Data Engineering and Clinical Data Standards
While the Clinical Data Standards provides the standards for clinical operation and data flow, the Clinical Data Engineering team drives the data architecture for clinical data
CDS also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis. Principal Data Configuration Engineer (DCE), Clinical Data Sciences (CDS): Key to Takeda’s success is the Clinical Data Engineering team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables
CDCS leads the integration of collected data from all sources by setting up proper configuration of data extraction and mapping of raw data into the Common Data Model for individual studies using processes and by the Data Engineer
Work with Data Engineer to configure (Extract Transform Load) ETLs and (Extract Load and Transform) ELTs
Provide testing and documentation for data pipelines
Utilize and contribute to libraries for functions and transformation templates for reuse for study level configuration tasks. The Principal Data Configuration Engineer (DCE), configures and maintains the data pipelines that conform to the common data model that ensures data ingestion for all study-level data capture technologies and other related vendor and/or applications (e.g., EDC, IRT, ePRO, eCOA)
Lias cross functionally, and provides mentoring and oversight that facilitates test data transfer, and confirms accurate DTA specification
Performs tasks to, configure, maintain, and monitor data flow integration between collected data and the clinical data repository (CDR)
DCE contributes to the successful conduct of Takeda’s clinical trials and to the delivery of high quality in a timely manner, which is eventually used for statistical analysis and submitted to regulatory authorities for the approval of Takeda products
Further, CDCS efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and achieve company objectives. Key Accountabilities: Advanced knowledge and ability to liase with outside groups in a matrix environmentThorough understanding of industry standards and ways of workingUnderstand FDA requirements and ability to defend work in auditAbility to mentor and train other team membersConfigure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by the Data Transfer Agreement and other specifications provided by Data Engineer Partner closely with internal/external stakeholders and data engineers in a collaborative manner Ensure accurate delivery of data format and data frequency with quality deliverables per specification Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business Additional Activities: Provide input for SOP creationMentor and guide other team membersProvide leadership for process workstreamsAssists with quality review of above activities performed by a vendor, as needed. Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. Ensure compliance with own Learning Curricula, corporate and/or GxP requirements
Performs other duties as assigned within timelines Qualifications: Bachelor's degree plus minimum of 7+ years’ experience (Sr
Manager)in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job
Experience with EDC build, Data Management, and EDC extraction configuration Knowledge of data flow between clinical data management systems, vendor devices and CDR. Knowledge of XMLS, ALS, APIs and MDR preferred. Experience with one of these languages: SQL, SAS, R, Python Understanding of SDTM Strong working knowledge of clinical trial terminology and data transfer specification expected Demonstrated ability to lead projects and work groups
Strong project management skills
Proven ability to resolve problems independently and collaboratively. Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Ability to work independently, take initiative and complete tasks to deadlines. Special Skills/Abilities: Strong attention to detail, and organizational skills Good time management skills Quick learner and comfortable asking questions, learning new technologies and systems Good knowledge of office software (Microsoft Office). Experience with EDC build or data extraction configuration ETL/ELT experience Understanding of AWS/Data bricks concepts Preferable but not required: Experience developing R shiny and Python apps Experience with Agile development methods Experience with Veeva CDB License/Certifications: Preferred to have SAS or R or Python certificationThis position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.Takeda Compensation and Benefits SummaryWe 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:Cambridge, MAU.S
Base Salary Range:$133,000.00 - $209,000.00The 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 from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 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. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeSummaryLocation: Cambridge, MAType: Full time
I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionKey to Takeda’s success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables
The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis. The Clinical Data Sciences comprises of the Clinical Data Engineering and Clinical Data Standards
While the Clinical Data Standards provides the standards for clinical operation and data flow, the Clinical Data Engineering team drives the data architecture for clinical data
CDS also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis. Principal Data Configuration Engineer (DCE), Clinical Data Sciences (CDS): Key to Takeda’s success is the Clinical Data Engineering team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables
CDCS leads the integration of collected data from all sources by setting up proper configuration of data extraction and mapping of raw data into the Common Data Model for individual studies using processes and by the Data Engineer
Work with Data Engineer to configure (Extract Transform Load) ETLs and (Extract Load and Transform) ELTs
Provide testing and documentation for data pipelines
Utilize and contribute to libraries for functions and transformation templates for reuse for study level configuration tasks. The Principal Data Configuration Engineer (DCE), configures and maintains the data pipelines that conform to the common data model that ensures data ingestion for all study-level data capture technologies and other related vendor and/or applications (e.g., EDC, IRT, ePRO, eCOA)
Lias cross functionally, and provides mentoring and oversight that facilitates test data transfer, and confirms accurate DTA specification
Performs tasks to, configure, maintain, and monitor data flow integration between collected data and the clinical data repository (CDR)
DCE contributes to the successful conduct of Takeda’s clinical trials and to the delivery of high quality in a timely manner, which is eventually used for statistical analysis and submitted to regulatory authorities for the approval of Takeda products
Further, CDCS efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and achieve company objectives. Key Accountabilities: Advanced knowledge and ability to liase with outside groups in a matrix environmentThorough understanding of industry standards and ways of workingUnderstand FDA requirements and ability to defend work in auditAbility to mentor and train other team membersConfigure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by the Data Transfer Agreement and other specifications provided by Data Engineer Partner closely with internal/external stakeholders and data engineers in a collaborative manner Ensure accurate delivery of data format and data frequency with quality deliverables per specification Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business Additional Activities: Provide input for SOP creationMentor and guide other team membersProvide leadership for process workstreamsAssists with quality review of above activities performed by a vendor, as needed. Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. Ensure compliance with own Learning Curricula, corporate and/or GxP requirements
Performs other duties as assigned within timelines Qualifications: Bachelor's degree plus minimum of 7+ years’ experience (Sr
Manager)in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job
Experience with EDC build, Data Management, and EDC extraction configuration Knowledge of data flow between clinical data management systems, vendor devices and CDR. Knowledge of XMLS, ALS, APIs and MDR preferred. Experience with one of these languages: SQL, SAS, R, Python Understanding of SDTM Strong working knowledge of clinical trial terminology and data transfer specification expected Demonstrated ability to lead projects and work groups
Strong project management skills
Proven ability to resolve problems independently and collaboratively. Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Ability to work independently, take initiative and complete tasks to deadlines. Special Skills/Abilities: Strong attention to detail, and organizational skills Good time management skills Quick learner and comfortable asking questions, learning new technologies and systems Good knowledge of office software (Microsoft Office). Experience with EDC build or data extraction configuration ETL/ELT experience Understanding of AWS/Data bricks concepts Preferable but not required: Experience developing R shiny and Python apps Experience with Agile development methods Experience with Veeva CDB License/Certifications: Preferred to have SAS or R or Python certificationThis position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.Takeda Compensation and Benefits SummaryWe 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:Cambridge, MAU.S
Base Salary Range:$133,000.00 - $209,000.00The 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 from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 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. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeSummaryLocation: Cambridge, MAType: Full time
Source : Takeda