Associate Director, Data Validation Engineer
Takeda
14 days ago
Remote
United States
$154,400 - $242,550 USD yearly
IT
Objective / Purpose
This Associate Director, Data Validation Engineer (DVE) role supports Clinical Trial Reporting by delivering data listings and visualizations to enable high-quality data for timely statistical analysis and regulatory submissions. Partners with Clinical Data Management and study teams to define listing/visualization specifications and to build/oversee data review objectives and artifacts, including reusable libraries (functions and transformation templates). Maintains, tests, documents programming tasks, and ensures compliance with Trial Master File (TMF) requirements.
Accountabilities
- Provide clinical trial reporting expertise and leadership for global and post-marketing studies.
- Drive vendor strategy to ensure technology/regulatory compliance.
- Partner with Data Configuration Engineer and Clinical Data Standards on cleaning/quality checks, metrics, visualizations, and monitoring reports.
- Organize Clinical Trial Reporting and non-clinical data cleaning activities.
- Collaborate across EDC, data configuration, clinical operations/data management, statisticians, and programmers to develop/maintain data review objectives and libraries.
- Oversee FSP/vendor resourcing; may manage employees.
- Review/develop/maintain/optimize compliant reporting processes; train/mentor staff.
- Support clinical reporting talent development and technology enablement (e.g., cross-functional data review/cleaning).
- Lead audits/inspection readiness and participate in internal audits and regulatory inspections; confirm TMF archival/inspection readiness.
Education & Competencies
- BS/BA in health/life science or technology field.
- 8+ years drug development; 6+ years project management/leadership (programming team leadership is a plus).
- Experience with Veeva CDB, Elluminate, JReview; clinical database systems (Metadata Rave, Veeva); CQL/SQL/SAS/R/Python.
- Knowledge of data structures/data flow; vendor/technology implementation (e.g., Elluminate/Veeva CDB/CluePoint/JReview/R/RShiny).
- Pharma operational experience (data review, regulatory submissions, safety updates, etc.); FDA/ICH knowledge and best practices for computer system validation, e-records/e-signatures, and data privacy.
- Strong written/oral communication, leadership, decision-making, influencing, negotiation, and project management skills.
This Associate Director, Data Validation Engineer (DVE) role supports Clinical Trial Reporting by delivering data listings and visualizations to enable high-quality data for timely statistical analysis and regulatory submissions. Partners with Clinical Data Management and study teams to define listing/visualization specifications and to build/oversee data review objectives and artifacts, including reusable libraries (functions and transformation templates). Maintains, tests, documents programming tasks, and ensures compliance with Trial Master File (TMF) requirements.
Accountabilities
- Provide clinical trial reporting expertise and leadership for global and post-marketing studies.
- Drive vendor strategy to ensure technology/regulatory compliance.
- Partner with Data Configuration Engineer and Clinical Data Standards on cleaning/quality checks, metrics, visualizations, and monitoring reports.
- Organize Clinical Trial Reporting and non-clinical data cleaning activities.
- Collaborate across EDC, data configuration, clinical operations/data management, statisticians, and programmers to develop/maintain data review objectives and libraries.
- Oversee FSP/vendor resourcing; may manage employees.
- Review/develop/maintain/optimize compliant reporting processes; train/mentor staff.
- Support clinical reporting talent development and technology enablement (e.g., cross-functional data review/cleaning).
- Lead audits/inspection readiness and participate in internal audits and regulatory inspections; confirm TMF archival/inspection readiness.
Education & Competencies
- BS/BA in health/life science or technology field.
- 8+ years drug development; 6+ years project management/leadership (programming team leadership is a plus).
- Experience with Veeva CDB, Elluminate, JReview; clinical database systems (Metadata Rave, Veeva); CQL/SQL/SAS/R/Python.
- Knowledge of data structures/data flow; vendor/technology implementation (e.g., Elluminate/Veeva CDB/CluePoint/JReview/R/RShiny).
- Pharma operational experience (data review, regulatory submissions, safety updates, etc.); FDA/ICH knowledge and best practices for computer system validation, e-records/e-signatures, and data privacy.
- Strong written/oral communication, leadership, decision-making, influencing, negotiation, and project management skills.