When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is seeking an experiencedPrincipal Clinical Data Engineerto join our Global Data Operations team. This is a leadership position where you will be recognized as a subject matter expert, providing technical support and strategic guidance to internal and external sponsors while leading high-impact clinical data projects.
As Principal Clinical Data Engineer, you will take the lead on complex projects, liaise with sponsors, Data Management Leads, and cross-functional teams, while maintaining account oversight responsibilities. You will be instrumental in aggregating data from multiple sources and devices, managing external data, and driving operational efficiencies through the development of standards, libraries, and reusable tools.
Key Responsibilities:
Manage Projects & Technology
Lead and implement Data Receipt Agreements with vendors in collaboration with cross-functional teams
Program and establish import procedures for data ingestion using SAS or alternative technologies (e.g., Workbench)
Design and implement reconciliation checks to ensure accurate data transfer
Program offline listings and custom reports to provide valuable insights on external data
Aggregate data across all sources and manage data structures, missing values, and programming errors
Review data outputs and provide strategic insights to study teams and clients
Ensure first-time quality on all deliverables
Negotiate electronic data timelines and ensure adherence through active project management
Monitor project resourcing, identify scope changes, and resolve technical issues
Coordinate and lead programming teams to successful project completion within timelines and budget
Manage deployment of data management technology for offline listing creation
Act as SME and technology owner for data management offline listing platforms
Documentation & Compliance
Maintain comprehensive supporting documentation in accordance with SOPs, Guidelines, and Work Instructions
Ensure traceability and regulatory compliance across all study activities
Document deviations and communicate them to project teams
Support Initiatives & Continuous Improvement
Participate in creating standards through tools (SAS macros), libraries, and processes
Develop and implement project-specific tools and improvements
Lead or drive global initiatives related to processes and new technologies
Mentor staff and provide relevant training
Assist project teams in problem resolution and technical support
Maintain and expand regulatory knowledge within the clinical research industry
Account Leadership & Business Development
Serve as point of contact for clients and internal stakeholders on electronic data matters
Participate in bid defense meetings
Independently contribute ideas on technology and data engineering to support business development
Required Skills & Experience:
Bachelor's degree (or equivalent) in a relevant science discipline is preferred, or equivalent work experience
Programming Proficiency:Advanced proficiency in at least one of the following: SQL, SAS, or R
Regulatory Knowledge:Comprehensive knowledge of SOPs, Guidelines, Work Instructions, System Life Cycle methodologies, ICH-GCP, and applicable regulations (e.g., 21 CFR Part 11) with proven practical application
Clinical Data Systems:Strong experience working with at least two systems used to aggregate data in the clinical trial process (e.g., SAS, Workbench, Elluminate)
Excellent interpersonal, oral, and written communication skills with concise, audience-tailored messaging and diplomatic approach
Highly developed problem-solving capabilities, root cause analysis skills, and ability to make decisions in ambiguous situations
Excellent analytical and technical capabilities
Written and oral fluency in English
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