Senior Clinical Data Engineer
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Job Description
Senior Clinical Data Engineer designing regulated data solutions for Parexel's clinical trials. Leading ingestion, validation, reporting, and technical teams in Hyderabad.
Responsibilities:
- 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
Benefits:
- Continuous learning opportunities
- Career paths and skill expansion across clinical research, data engineering, and regulatory science
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