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Description 【募集の背景 / Purpose & Scope】 The Clinical Data Architect and Engineer role serves the purpose of fostering innovation and operational efficiency through the facilitation of data-driven decision-making processes, expediting drug discovery initiatives, and bolstering regulatory compliance efforts. This role involves designing and implementing customized data architecture solutions tailored to the complexities of life sciences research and development. It also includes 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. Expertise in Data Engineering, Data Modeling, Business Intelligence (BI) technologies, and adeptly managing governance processes is essential for maintaining the integrity, security, and accessibility of data assets. This role holds a strategic position in advancing the life sciences company's mission by using data to drive scientific progress, improve patient outcomes, and efficiently and securely introduce groundbreaking therapies to the market. 【職務の内容 / Essential Job Responsibilities】 (雇入れ直後)

  • 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. (変更の範囲) 会社内での全ての業務 【組織 / Organizational Context】
  • Reports to Head of Foundational Data & Analytics
  • Works very closely with the Data & Analytics teams in ensuring overall architecture alignment of Data & Analytics platforms.
  • Communicate regularly with peers to update progress, discuss concerns, priorities, and projects.
  • Regular contact with subordinates to mentor them and their performance.
  • Supports team members in the interactions with senior business leaders to understand their longer-term needs, responding with architectures and plans, and providing expert consultancy.
  • Works with DigitalX Business Partners to Influence business leaders and business process owners to maintain consistency with Data architecture roadmap for their area.
  • Close collaboration with DigitalX Architecture & Technology teams.
  • Close collaboration with DigitalX Risk & Compliance to ensure the Platforms are fully compliant.
  • Communicate regularly with industry groups and suppliers.
  • Collaborate with external service provider account managers and senior SMEs. 【Other】
  • Assist with the management of a portfolio of 10+ toolsets and platforms 【応募要件 / Qualifications】
  • Expertise in database design, data modeling, and data integration techniques.
  • Proficiency in programming languages commonly used in data management and analysis, such as SQL, SAS, Python, or R.
  • Expertise in working with databases and data warehousing technologies like SQL Server, Oracle, MySQL, AWS Redshift, Azure Synapse, Google BigQuery etc.
  • Strong command in ETL and Data Integration tools like Talend, AWS Glue and DataBricks.
  • Experience with Master Data Management (MDM) tools like Veeva Network, Reltio and IBM Infosphere
  • Experience with BI tools like QlikSense, Tableau and PowerBI.
  • In-depth understanding of life sciences business processes, adept at translating business requirements into effective technical solutions.
  • Innovative problem-solving abilities for addressing complex data-related challenges.
  • Experience with Agile methodology and mindset.
  • Excellent communication and interpersonal skills, enabling effective collaboration with cross-functional teams, business stakeholders, and technical experts.
  • Project management capabilities, ensuring adherence to timelines for successful solution delivery.
  • Demonstrated leadership skills, including guiding technical teams, offering mentorship, and influencing architectural decisions.
  • Demonstrated commitment to staying current with the latest trends, technologies, and best practices in the data and analytics field.
  • Relevant certifications in cloud computing and data analytics tools/platforms are advantageous.
  • Bachelor of Science degree in Computer Science, Information Systems, Data Science, or a related field.
  • 10+ years of relevant experience working in in data architecture, engineering roles or related roles within a healthcare industry.
  • 7+ years experience in Life Sciences industry
  • Master of Science degree in Computer Science, Information Systems, Data Science, or a related field.
  • Advanced Analytics experience


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