Senior Manager, Clinical Data Configuration Engineer at Takeda

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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

Additional Activities:

• Provide input for SOP creation

• Mentor and guide other team members

• Provide leadership for process workstreams

• Assists 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 certification

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We 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:

U.S. Base Salary Range:

The 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-termincentives. 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 Statement

Takeda 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.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time