Clinical Data Informatics Specialist

Role: Clinical Data Information Specialist, R&DX

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact

Purpose and Scope:

The Clinical Data Information Specialist position is an exciting opportunity to significantly contribute towards the compliance requirements of Astellas, by developing relevant and applicable data management solutions on the Regulatory data modelling platform. This role is critical for managing regulatory information utilizing IDMP requirements as a baseline. It involves building a system landscape that unlocks the potential of data, wherein a centralized repository for accurate and up-to-date regulatory information.

In close collaboration with DigitalX Pod or Value Team Captains and business leads, this role will facilitate IDMP, CMC, and other regulatory requirements through the creation, governance, and maintenance of accurate, unique, and standardized data records and models, reducing time for product approvals. The role will be responsible for defining and implementing data modeling standards, business rules, data structures, and relationships that support regulatory data domains, while fully leveraging platform capabilities and functionality to enforce data standardization, quality, and uniqueness. This will be aligned with IDMP requirements to enable interoperability and seamless data exchange across internal and external systems.

Working with a diverse range of stakeholders across Research and Development (R&D) and DigitalX, the incumbent will be involved in designing and developing solutions including Master Data Management that render a good view of how the Clinical Trial Data, and Regulatory data, including the Pharmaceutical Product master data, is connected to all systems, pre-market, and FDA/EMA approved products, ensuring a molecule to market foundational solution for regulatory compliance

Responsibilities:

• Responsible for modelling Master Data Management (MDM) features and capabilities on Astellas enterprise platform. This role will work cross-functionally and is accountable for Business as Usual and new development activities.
• Acts as a Subject Matter Expert in Regulatory data (e.g. product data) and associated data standards (e.g. IDMP)
• Engages with business owners to define key business requirements and converts these requirements into data modelling and technical specifications.
• In accordance with business requirements, develop all aspects of the solution including but not limited to Data modelling, Data Load/Export, perform complex mapping, matching and survivorship rules, data cleansing, deduplication, standardization, and data model configuration.
• Be actively involved in testing and validation activities for all new development work. Coordinate with Foundation Data teams ensuring that Data Lakes and consuming systems reflect the accurate data.
• Partner with Data Governance Specialists and Data Stewards to define business glossary terms, controlled terminology, metadata requirements, stewardship, quality rules, classifications, and semantic standards.
• Map internal models to approved scientific, clinical, regulatory, and manufacturing ontologies, taxonomies, controlled vocabularies, and industry standards.
• Participate in design and code reviews to ensure solution capabilities deliver value, in partnership with key DigitalX and business stakeholders.
• Maintain applicable security access and privileges, mapping users' roles with appropriate Reltio custom roles.
• Identify use cases to harmonize data across Clinical Trial Management, and Regulatory Data ensuring tracing and tracking of data sets across Pre-commercial to Medicinal Products.
• Actively participate in maintaining the backlog of activities, on Azure DevOps services.