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Associate Manager, Clinical Data Validation Engineer

Employer
Takeda
Location
Cambridge, Massachusetts
Start date
Oct 18, 2024
View more categoriesView less categories
Discipline
Clinical, Clinical Data, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

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’sPrivacy 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 Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us an Associate Manager, Clinical Data Validation Engineer in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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 (CDE) 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.

Here, you will be a vital contributor to our inspiring, bold mission

OBJECTIVES:

The CDE team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. As part of CDE, the Clinical Data Validation Engineer (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.

ACCOUNTABILITIES:

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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Qualifications:

  • Bachelor's degree plus minimum of 2+ years’ experience 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.
  • 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
  • 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
  • Good 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.

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

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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:

Cambridge, MA

U.S. Base Salary Range:

96,600.00 - 151,800.00

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.

LocationsCambridge, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

Company

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.

 

Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future

For more information, visit https://jobs.takeda.com/

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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