Principal Clinical Data Engineer

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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.

• 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

• 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

• 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

• 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:

• Bachelors 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