Are you a skilled data engineering professional with a passion for clinical research? Parexel is seeking aSenior Clinical Data Engineerto join our Global Data Operations team. In this pivotal role, you will leverage your technical expertise to support the conduct of clinical trials, serve as an internal subject matter expert, and lead cross-functional projects with sponsors and data management teams.
As a Senior Clinical Data Engineer, you will work independently and collaboratively to manage electronic data, eClinical technologies, and systems while maintaining the highest standards of quality and regulatory compliance. You will also mentor team members and drive process improvements across the organization.
Key Responsibilities
Project & Technology Management
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.)
Documentation & Compliance
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
Standards & Process Improvement
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
Required Skills & Experience:
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
Bachelor's degree (or equivalent) in a relevant science discipline
Application of Clinical Research Standards (CRS) concepts
Root cause analysis capability
Fluent written and oral English
Required Experience & Knowledge
Proficiencyin at least one of the following: SQL, SAS, or R
Knowledgeof SOPs, guidelines, work instructions, system life cycle methodologies, ICH-GCP, and applicable regulations (e.g., 21 CFR Part 11)
Proven practical applicationof regulatory and compliance frameworks
Experienceworking with at least two systems used to aggregate data in clinical trials (e.g., SAS, Workbench, Elluminate)
Strong backgroundin clinical research industry or similar field
#LI-REMOTE
