Note: The job is a remote job and is open to candidates in USA. Parexel is seeking a Senior Clinical Data Engineer to join their Global Data Operations team. In this pivotal role, you will leverage your technical expertise to support the conduct of clinical trials and lead cross-functional projects with sponsors and data management teams.
Responsibilities
- Lead and implement Data Receipt Agreements with vendors through cross-functional collaboration
- Program and configure import procedures for data ingestion using SAS, Workbench, or alternative technologies
- Design and execute reconciliation checks to ensure accurate data transfer
- Program offline listings and custom reports to provide actionable insights
- Aggregate data across multiple sources and manage external data effectively
- Handle missing values, raw data files, data structures, and SAS dataset operations
- Review and analyze data outputs to provide insights to study teams and clients
- Ensure first-time quality on all deliverables
- Manage electronic data timelines and coordinate with project teams
- Lead programming teams to successful study completion within timelines and budget
- Deploy and manage data management technology (Workbench, SAS, R, etc.)
- Maintain comprehensive study documentation in accordance with SOPs, guidelines, and work instructions
- Ensure traceability and regulatory compliance across all activities
- Document deviations and communicate them to project teams
- Participate in creating standards through tools (SAS macros, libraries, processes)
- Develop and implement project-specific tools and templates
- Improve efficiencies through standardized project structures and naming conventions
- Support business development and bid defense meetings
Skills
- Bachelor's degree (or equivalent) in a relevant science discipline
- Proficiency in at least one programming language (SQL, SAS, or R)
- Strong analytical and problem-solving skills
- Ability to make informed decisions in ambiguous situations
- Application of Clinical Research Standards (CRS) concepts
- Root cause analysis capability
- Fluent written and oral English
- Knowledge of SOPs, guidelines, work instructions, system life cycle methodologies, ICH-GCP, and applicable regulations (e.g., 21 CFR Part 11)
- Proven practical application of regulatory and compliance frameworks
- Experience working with at least two systems used to aggregate data in clinical trials (e.g., SAS, Workbench, Elluminate)
- Strong background in clinical research industry or similar field
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