Senior Clinical Data Engineer

đŸ”„ 0 minutes ago

🇼🇳 India – Remote

⏰ Full Time

🟠 Senior

🚰 Data Engineer

đŸ‘» Ghost score 10%

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Logo of Parexel

Parexel

10,000+ employees

Founded 1983

đŸ’Œ Consulting

đŸ„ Healthcare

📩 Logistics

💰 Venture Round on 1990-01

Consulting ‱ Healthcare ‱ Logistics

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 the design, implementation, and management of Data Receipt Agreements with vendors ‱ Coordinate with cross-functional teams to establish data transfer protocols ‱ Program and establish data import procedures using SAS, SQL, R, Workbench, or alternative technologies ‱ Develop and execute reconciliation checks and validation protocols ‱ Design and program offline listings and custom reports ‱ Aggregate and manage data from multiple sources, including missing values, raw data files, and complex data structures ‱ Review and analyze data outputs to identify patterns, anomalies, and improvement opportunities ‱ Ensure first-time quality and compliance with SOPs, regulatory guidelines, ICH-GCP, and 21 CFR Part 11 ‱ Lead programming teams to complete projects within timelines and budgets ‱ Monitor resourcing and manage scope changes ‱ Manage deployment and optimization of data management technologies ‱ Develop and maintain technical documentation, data standards, and quality processes ‱ Mentor team members and project teams ‱ Participate in bid defense meetings and business development activities

🎯 Requirements

‱ Bachelor's degree in a relevant science discipline or equivalent work experience ‱ Minimum 5+ years of experience in clinical research, data management, or a related field ‱ Advanced proficiency in at least one programming language: SAS, SQL, or R ‱ Demonstrated expertise in data manipulation and analysis ‱ Hands-on experience with at least two clinical data management systems, such as SAS, Workbench, or Elluminate ‱ Strong knowledge of ICH-GCP, regulatory requirements, SOPs, system life cycle methodologies, and 21 CFR Part 11 ‱ Demonstrated leadership experience mentoring team members and managing technical projects ‱ Strong leadership and mentoring capabilities ‱ Strong analytical and strategic thinking skills ‱ Excellent written and oral communication skills in English ‱ Ability to present complex technical information clearly to diverse audiences ‱ Experience working in clinical research or regulated environments ‱ Ability to work with multiple data management systems and adapt to evolving technical landscapes

đŸ–ïž Benefits

‱ Continuous learning opportunities ‱ Career paths and skill expansion across clinical research, data engineering, and regulatory science

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