Clinical Data Architect and Engineer
4 weeks ago
Astellas Canada is seeking a Clinical Data Architect & Engineer to join our team.
The ideal candidate will have expertise in designing and implementing customized data architecture solutions tailored to the complexities of life sciences research and development.
This role involves supervising the integration and management of various data sources, such as clinical trials data, operational data, genomic data, and real-world evidence.
Through close collaboration with research scientists, statisticians, clinicians, regulatory experts, and DigitalX professionals, this role establishes and upholds robust data architecture frameworks that align harmoniously with business objectives, regulatory mandates, and industry standards.
Key Responsibilities:
- Develop and maintain comprehensive data architecture strategies tailored to the unique needs of Clinical and Operational data management.
- Design scalable, efficient, and secure databases, data warehouses, and data lakes to store and manage clinical data effectively.
- Define and implement data models, schemas, and integration frameworks to ensure the integrity and accessibility of clinical data.
- Lead all data engineering tasks and implement data pipelines, ETL processes to ingest, transform, and load clinical data from various sources into the data infrastructure.
- Optimize data workflows and performance through automation, parallel processing, and data partitioning techniques.
- Collaborate with data scientists and analysts to support advanced analytics, machine learning, and predictive modeling initiatives.
- Integrate disparate clinical systems, applications, and data sources to enable interoperability and data exchange across the life sciences ecosystem.
- Develop APIs, interfaces, and middleware solutions for seamless communication between clinical software systems and databases.
- Ensure compatibility and compliance with industry standards such as HL7, FHIR, and others.
- Implement security controls, encryption mechanisms, and access management policies to protect sensitive data from unauthorized access, breaches, and cyber threats.
- Monitor compliance with healthcare regulations such as HIPAA, GDPR, and other data privacy laws, and implement measures to address potential risks and vulnerabilities.
- Conduct performance tuning and optimization of databases, queries, and data processing pipelines to enhance efficiency, reliability, and scalability.
- Monitor system health, data integrity, and performance metrics using monitoring tools and implement proactive measures to address issues and bottlenecks.
- Document data architecture designs, technical specifications, and operational procedures to facilitate knowledge transfer and support ongoing maintenance and enhancements.
- Provide guidance, training, and mentorship to team members and stakeholders on best practices in data management, architecture, and engineering.
- Work closely with cross-functional teams including statisticians, statistical programmers, researchers, DigitalX members, and regulatory experts to understand requirements and priorities for clinical data management and analysis.
- Communicate effectively with stakeholders to ensure alignment of data architecture and engineering solutions with organizational goals and objectives.
- Stay abreast of emerging technologies, trends, and best practices in clinical data management, architecture, and engineering.
- Identify opportunities for process improvement, automation, and innovation to enhance the efficiency and effectiveness of data management practices.
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