Clinical Data Engineer (Manager/Sr. Manager) - Alta Petens
Company: Takeda Pharmaceutical
Location: Clifton
Posted on: January 19, 2023
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Job Description:
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Job Description
Clinical Data Sciences (CDS) at Takeda:
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.
Clinical Data Engineer (CDE), 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. CDE leads the
integration, design, development, and execution of data pipelines
for the ingestion of clinical data from all sources at an
enterprise level for use by the clinical data configuration
specialist at the study level. The CDE is an enterprise level role
and is primarily responsible for ensuring smooth end to end
processes for data collection/ingestion from all data collection
sources, providing an output into a data lake that is fit for use
by downstream end users. The CDE is also responsible for developing
and tracking KPIs and other measures across the business and
providing continuous improvement for both process and tools. The
CDE will also develop and maintain libraries, tools, and reports to
increase reuse and overall efficiency for study level roles. The
CDE should have a strong understanding of end-to-end clinical data
collection and extraction processes as well as strong project
management and technical experience. The CDE will be working with
cross functional stakeholders to ensure alignment on processes and
requirements and often will be required to convert these
requirements to technical specifications. The CDE may also need to
develop tools and visualizations as part of the continuous
improvement process.
Under the guidance of Clinical Data Sciences, the Clinical Data
Engineer provides leadership and guidance at the enterprise level
for end-to-end data extraction, transformations and construct of
data pipelines that conform to the common data model that ensures
data ingestion for all clinical data capture technologies and other
related vendor and/or applications (e.g., EDC, IRT, ePRO, eCOA) as
well other data models that may be required by end users.
Understands and ensures proper data formats for all downstream
users for use in the data lake. Facilitates test data transfer to
staging instance and confirms accurate DTA specification. Defines
processes and develop and maintain code libraries for use by
clinical data configuration specialist to build, maintain, and
monitor data pipelines for clinical data and the clinical data
repository (CDR) alongside processing specialty data for
exploratory analysis.
Develops and maintains library of reusable mapping and
transformation functions to be used across studies. CDE 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. The CDE also
monitors end to end performance and KPIs and provides continuous
improvement to processes and tools. Further, CDE efforts enable
valid secondary use of clinical trial data throughout Takeda
research groups to maximize value and achieve company
objectives.
Key Accountabilities:
Educational Qualification:
Experience:
Keywords: Takeda Pharmaceutical, Clifton , Clinical Data Engineer (Manager/Sr. Manager) - Alta Petens, Healthcare , Clifton, New Jersey
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