Associate Director, Data Validation Engineer

SoTalent is seeking an experienced leader for the role of Associate Director, Data Validation Engineer, focusing on clinical trial reporting activities. The successful candidate will oversee data validation tasks, collaborate with cross-functional teams, and ensure high-quality data delivery for statistical analysis and regulatory submissions.

Responsibilities:

• Lead clinical trial reporting for development and post-marketing studies, providing subject-matter expertise and strategic direction
• Collaborate with data engineering and standards teams to design data quality checks, study status metrics, visualizations, and monitoring reports
• Define and organize reporting and data cleaning activities for assigned studies
• Drive vendor strategy and oversight to ensure technology and deliverables meet regulatory standards
• Work closely with EDC developers, data engineers, clinical operations, data managers, statistical programmers, and statisticians to develop and govern standard data review objectives and libraries
• Manage and mentor staff, including potential direct reports, and support talent development within the team
• Support process improvements, technology enablement (e.g., cross-functional data review/cleaning), and governance to maintain compliance and efficiency
• Represent the function during audits and inspections and ensure trial documentation is inspection-ready

Requirements:

• Bachelor's degree in life sciences, health-related, or technology field
• 8+ years of drug development experience
• 6+ years of project management and leadership experience
• Experience with listings and visualizations using platforms such as Veeva CDB, Elluminate, JReview, or similar
• Familiarity with clinical database systems (e.g., Metadata Rave, Veeva) and programming languages such as CQL, SQL, SAS, R, or Python
• Strong understanding of data flows between clinical systems, devices, and central repositories
• Experience managing vendors and implementing clinical technologies (e.g., Elluminate, Veeva CDB, CluePoint, JReview, RShiny)
• Operational experience in clinical development and data operations, including regulatory submissions and data review
• Knowledge of FDA/ICH regulations, computer system validation, electronic records/signatures, and data privacy principles
• Strong communication, leadership, influencing, and project management skills