Mgr/Sr Mgr Clinical Data Validation Engineer

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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 Validation Engineer (DVE), Clinical Data Sciences (CDS):

The CDE team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. As part of CDE, the DVE group leads 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. The DVE team works alongside the other CDE teams to ensure adherence to Takeda standards and GCP principles. DVEs are vital to all data cleaning and reconciliation efforts 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. DVEs also utilize and contribute to the development of libraries for functions and transformation templates for reuse for study level validation tasks.DVEs are responsible for maintaining, testing and documentation of programming code and ensure compliance with trial master file requirements. Additionally, DVEs will utilize existing tools and utilities to program validation checks and listings in using novel application specific coding processes.

DVEs 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. Further, the DVE team’s efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and achieve company objectives.

Key Accountabilities:

• 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.
• Partner closely with internal/external stakeholders and data engineers in a collaborative mannerto ensure proper specification and testing documentation.
• Ensure accurate delivery of all data validation tasks adhering to established timelines and internal processes.
• 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.

Additional Activities:

• 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 5+ years’ experience (Manager), 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 clinical database systems (Metadata Rave, Veeva, InForm) 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 is 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.
• Great time management skills.
• Quick learner and comfortable asking questions, learning new technologies and systems
• Good knowledge of office software (Microsoft Office).
• 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, R or Python certification.

Physical Demands:

• Ability to sit and stand for long periods of time.
• Carrying, handling, and reaching for objects.
• Manual dexterity to operate office equipment i.e. computers, phones, etc.

Travel Requirements:

• Requires approximately 1-2 domestic trips annually and up to 1 international trip.

Additional Information:

• Base Salary Range: $105,000.00 to $150,000.00. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
• This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

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.