Your Role:
We are seeking a highly skilled and experienced Data Architect for Clinical Trial Systems. This role requires a strong background in both clinical operations and data architecture & standards, as well as a deep understanding of the environment within the healthcare industry.
In the role of the Data Architect for Clinical Trial Systems you will lead the design and implementation of data solutions that support our clinical trial processes, ensuring data integrity, security, and compliance with regulatory standards.
We aim to establish new internal clinical trial systems (EDC, CTMS, SSU, and eTMF) to reduce fragmentation of operational activities, increase transparency & real-time access to data, and to leverage the benefits of GenAI/AI technologies. Establishing data standards, data flows and integrations is key for the success of this initiative.
You will operationalize our data strategy into established end-2-end data flows and streamline integration architecture & technical standards for this space. This will include defining efficient data flows between the involved transactional systems as well as to a central data repository. In addition, you will define an efficient setup for the exchange of master & reference data. Your work will include strong collaboration with the data governance function, business process owners, and the program organization for system setup and configuration.
Who You Are:
1. Master's degree in a relevant field
2. At least 10 years of experience in data architecture, with a focus on clinical trial systems and healthcare data
3. Deep understanding of the clinical systems landscape (i.e. EDC, CTMS & SSU and eTMF) and technology trends
4. Strong knowledge of industry data standards
5. Strong knowledge of regulatory requirements, including GXP and other relevant guidelines.
6. Excellent leadership, communication, and stakeholder management skills, with the ability to build consensus and drive decision-making.
7. Project management certification (e.g., PMP) is a plus
Department: HC-HF-IRD Global Development Operations & SPH
Role Level: Expert 3
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