Senior Manager, Clinical Data Configuration Engineer

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Job Description

Key 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 environment

• Thorough understanding of industry standards and ways of working

• Understand FDA requirements and ability to defend work in audit

• Ability to mentor and train other team members

• Configure 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