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Associate Manager, Data Validation Engineer

Takeda Pharmaceutical Company

Cambridge, MA
Full Time
Senior
150k-221k
14 days ago

Job Description

About the Role

Takeda Development Center Americas, Inc. is seeking an Associate Manager, Data Validation Engineer to provide strategic planning, integration, execution, and oversight of clinical trial deliverables. The role involves leading data validation, reconciliation, and cleaning efforts to ensure high-quality, compliant data for clinical trials, supporting regulatory submissions and audit readiness. The position offers up to 100% remote work and contributes to the successful conduct of Takeda's clinical trials.

Key Responsibilities

  • Provide strategic planning, integrating, execution, build and oversight of clinical trial deliverables.
  • Program study level clinical data validation checks, reconciliation listings and related data cleaning reports adhering to internal processes, approved standards and specifications.
  • Utilize and contribute to the development of libraries for functions and transformation templates for reuse in study level validation tasks.
  • Lead validation and reconciliation efforts of collected data, programming data validation listings, reconciliation checks and reports in a controlled and consistent manner.
  • Perform data cleaning and reconciliation and work cross-functionally with Clinical Study teams to foster an environment of quality and efficient documentation.
  • Coordinate maintaining, testing and documentation of programming code and ensure compliance with trial master file requirements.
  • Contribute to the successful conduct of clinical trials and timely delivery of high-quality data for statistical analysis and regulatory submission.
  • Work alongside other CDE teams to ensure adherence to Takeda standards and GCP principles.
  • Participate in the development of new processes and best practices and assist with training and awareness for other business groups.

Requirements

  • Bachelor's degree in Computer Science, Information Technology, Statistics, Analytics, Biostatistics, Mathematics, Biology or health-related field.
  • At least 5 years of related experience in data validation, reconciliation, and data processing.
  • Experience ensuring data validity through conformance checks and reconciling clinical study data from various sources.
  • Ability to acquire, process, clean, integrate and store data, and communicate data issues for resolution.
  • Experience maintaining project documentation, testing, verification, and quality control documents ensuring inspection readiness.
  • Knowledge of clinical drug development, industry standards, and electronic submission requirements.

Qualifications

  • Bachelor's degree in relevant field.

Benefits & Perks

  • Competitive compensation and benefits.
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Job Details

Posted AtJul 11, 2025
Job CategoryQA Engineering
Salary150k-221k
Job TypeFull Time
Work ModeRemote
ExperienceSenior

Job Skills

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About Takeda Pharmaceutical Company

Website

takeda.com

Location

Cambridge, MA

Industry

Pharmaceutical Preparation Manufacturing

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