Associate Director, Data Validation Engineer

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Job Description

 Objective / Purpose: 

This Associate Director, Data Validation Engineer (DVE) role will work on Clinical Trial Reporting activities to deliver data listings and visualizations to facilitate the delivery of high-quality data in a timely manner, leading to statistical analysis and submission to regulatory authorities. This role partners with Clinical Data Management and works with Takeda study teams to develop listings and visualizations specifications, build and/or oversee implementation of data review objectives/artifacts for clinical trials to support the overall data review plan. In addition, this role will utilize and contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study level validation tasks. DVEs are responsible for maintaining, testing and documentation of programming tasks and ensuring compliance with trial master file requirements. This role operates in compliance with Takeda SOPs and processes while working closely with Clinical Data Operations Functions and others to enhance existing processes. 

Accountabilities:  

• Provides clinical trial reporting expertise and leadership in support of global development programs as well as post-marketing registration and non-registration studies. 

• Drives strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance. 

• Partners with Data Configuration Engineer, and Clinical Data Standards teams in the development of standard and study specific data cleaning/quality checks, study status metrics, visualizations and monitoring reports.  

• Organizes Clinical Trial Reporting activities for assigned clinical studies and non-clinical data cleaning activities 

• Foster and ensure close collaboration with study team members (e.g., EDC Developers, Data Configuration engineer, Clinical Operations, Clinical Data Managers, Statistical Programmers, Statisticians and other stakeholders) in the clinical data lifecycle and in the development /maintenance/governance of standard data review objectives and libraries 

• Assists with oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects. 

• Might be responsible for direct line management of employees. 

• Establishes and maintains productive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third-party service providers. 

• Responsible for the review, development, maintenance and optimization of processes to ensure that clinical trial reporting activities are in compliance with regulatory and company requirements 

• Training and mentoring staff on key activities and processes. 

• Recognizes development needs and identifies/creates development opportunities within team  

• Supports the development of the clinical trial reporting talent base and identifies development needs within the area of responsibility  

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