Manager, Clinical Data Validation Engineer

$108,500 - $108,500/Yr

Takeda Pharmaceutical Company - Cambridge, MA

Full-time - Manager

Remote - Cambridge, MA

Chemical Manufacturing

About the position

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.

Responsibilities

• 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 manner to 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.
• Assist with quality review of 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.

Requirements

• Bachelor's degree plus minimum of 5+ 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.
• 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.

Nice-to-haves

• Experience developing R shiny and Python apps
• Experience with Agile development methods
• Experience with Veeva CDB

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) plan with company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Sick time
• Paid vacation accrual up to 120 hours per year