Principal Clinical Data Engineer

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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 • 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 • 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

🎯 Requirements

• Bachelor's degree (or equivalent) in a relevant science discipline is preferred, or equivalent work experience • Advanced proficiency in at least one of the following: SQL, SAS, or R • 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 • Strong experience working with at least two systems used to aggregate data in the clinical trial process (e.g., SAS, Workbench, Elluminate) • Written and oral fluency in English

🏖️ Benefits

• Health insurance • Professional development opportunities