Senior Clinical Data Engineer

Key Responsibilities

• Lead the design, implementation, and management of Data Receipt Agreements with vendors and coordinate with cross-functional teams to establish efficient data transfer protocols
• Program and establish import procedures for data ingestion using SAS, SQL, R, or alternative technologies such as Workbench, ensuring seamless integration of external data sources
• Develop and execute comprehensive reconciliation checks and validation protocols to ensure accurate and complete data transfer across all systems
• Design and program offline listings and custom reports that provide actionable insights to study teams and clients, enabling data-driven decision making
• Aggregate and manage data across multiple sources, handling missing values, raw data files, data structures, and complex programming challenges with precision and accountability
• Review and analyze data outputs to identify patterns, anomalies, and opportunities for improvement, providing strategic insights to enhance study quality and efficiency
• Maintain accountability for first-time quality on all deliverables, ensuring compliance with SOPs, regulatory guidelines, and industry standards including ICH-GCP and 21 CFR Part 11
• Lead and coordinate programming teams to successful project completion within established timelines and budgets, while monitoring resourcing and managing scope changes
• Manage the deployment and optimization of data management technologies including SAS, Workbench, R, and other systems used for creating offline listings and data solutions
• Develop, implement, and maintain technical documentation, data standards, and quality processes that ensure traceability, regulatory compliance, and operational efficiency
• Mentor and provide technical guidance to team members and project teams, fostering a culture of continuous improvement and technical excellence
• Participate in business development activities including bid defense meetings, contributing technical expertise to support new business opportunities

You'll thrive in this role if you bring

Required Qualifications

• Bachelor's degree in a relevant science discipline or equivalent work experience
• Minimum 5+ years of experience in clinical research, data management, or a related field
• Proficiency in at least one programming language (SAS, SQL, or R) with demonstrated expertise in data manipulation and analysis
• Hands-on experience working with at least two clinical data management systems (such as SAS, Workbench, or Elluminate)
• Strong knowledge of ICH-GCP, regulatory requirements, SOPs, system life cycle methodologies, and applicable regulations including 21 CFR Part 11
• Demonstrated leadership experience mentoring team members and managing technical projects
• Excellent written and oral communication skills in English with the ability to present complex technical information clearly to diverse audiences