Senior 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

• 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

🎯 Requirements

• 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 • Proficiency in at least one of the following: SQL, SAS, or R • 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

🏖️ Benefits

• N/A