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Clinical Data Standards and Master Data Digital Solution Lead

External
Roche logoRoche · Madrid, Spain
Full-timeOn-siteToday
ComplianceLeadershipStakeholder Management
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At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As a Digital Solution Lead at this level, you lead the strategy, operating model, and delivery governance for Clinical Data Standards, Master Data, and the supporting technology ecosystem, including Roche's in-house standards and reference data platforms (Global Clinical Data Standards Repository (GDSR) and Lynx). You partner with PD Data Sciences, Clinical Data Management, Biostatistics, Study Teams, Roche Data Technologies, and Enterprise Informatics to ensure clinical data is defined once, governed consistently, delivered reliably, and reused at scale. This role requires deep expertise in CDISC and semantic modelling, combined with strong delivery leadership, to shape interoperable, metadata-driven foundations and ensure the associated platforms are run with the right quality, compliance, and service levels. Description of the area Within PD Data Sciences, this area is responsible for defining, governing, and operationalizing the standards and master data that underpin Roche's clinical data landscape. The team ensures consistent use of clinical data standards, controlled terminology, metadata, and master/reference data across protocol design, data collection, transformation, analysis, submission, and downstream reuse. It also drives the roadmap and business-facing direction for the in-house technologies that manage these assets (GDSR and Lynx), enabling study teams and downstream analytical environments to consume trusted standards and master data through governed, reusable services. A key focus of the area is advancing semantic interoperability across the clinical ecosystem. This includes developing semantically rich information models, metadata structures, and linked data concepts that improve traceability, reuse, and machine readability across clinical workflows. By combining strong governance with fit-for-purpose technology and disciplined delivery management, the team creates AI-ready foundations that allow analytics and agentic solutions to reason over high-quality, well-defined clinical data assets safely and consistently, while sustaining operational reliability, release quality, and business continuity for downstream consumers. Job Responsibilities Scope / (Content Leadership): Leads the domain vision for Clinical Data Standards, Master Data, and supporting technologies, shaping cross-functional strategy, governance, priorities, and delivery models. Acts as a subject matter expert in CDISC, master/reference data management, and semantic modelling, while setting clear expectations for platform health, release quality, and vendor or partner accountability. Accountability/Problem Solving: Leads resolution of complex issues spanning data standards adoption, metadata definition, master data stewardship, technology integration, and downstream consumption. Establishes transparent tracking for roadmap delivery, defects, incidents, and service health; anticipates gaps in process, governance, and architecture; conducts root cause analysis across organizational boundaries; and drives sustainable solutions that improve data quality, lineage, platform reliability, and operational efficiency. Stakeholder Management: Builds trusted partnerships across PD Data Sciences, Clinical Data Management, Biostatistics, Study Teams, Regulatory, Roche Data Technologies, Enterprise Data, Architecture, Informatics, and external delivery partners. Translates between scientific, operational, and technical stakeholders, acts as a trusted liaison between business owners and technical delivery teams, and proactively escalates material risks, blockers, and resource needs to maintain momentum and alignment. Impact/Strategy: Defines and drives the roadmap for clinical standards and master data capabilities, including evolution of in-house platforms such as GDSR and Lynx, metadata services, and semantic assets. Connects domain strategy to broader enterprise data and AI ambitions, while shaping success measures, increment planning, and the longer-term capability view needed to sustain compliant, reusable, and business-critical services. Complexity/ (Product Size): Operates across a highly interconnected domain supporting multiple studies, programs, vendors, and downstream consumers, with dependencies across standards, metadata, master data, integrations, platform operations, and governance processes. Manages ambiguity where regulatory expectations, business priorities, service continuity, and technical constraints must be balanced across both strategic change a


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