Takeda Pharmaceutical Company - Cambridge, MA
posted 2 months ago
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 as a 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. The Clinical Data Sciences (CDS) team at Takeda is key to our success, providing strategic planning, integration, execution, build, and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across various data sources, setup, data transfer/review, and support downstream transformation and analysis. The Clinical Data Sciences comprises the Clinical Data Engineering (CDE) and Clinical Data Standards. While the Clinical Data Standards provide 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 modeling, simulation, and analysis. As a vital contributor to our inspiring mission, the CDE team provides strategic planning, integrating, execution, build, and oversight of clinical trial deliverables. 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 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. They are responsible for maintaining, testing, and documenting programming code and ensuring compliance with trial master file requirements. Additionally, DVEs will utilize existing tools and utilities to program validation checks and listings 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.