Clinical Data Standards and Master Data Digital Solution Lead
Roche · Madrid ·
- Seniority
- Lead
- Company size
- 1000+
Roche · Madrid ·
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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 and day-to-day delivery realities.
Business/Technical ability: Combines strong business consulting skills with deep technical fluency in CDISC, semantic modelling, metadata-driven architecture, data modelling, master data technologies, and delivery governance. Leads technology advocacy for the domain, shapes requirements for in-house solutions, supports effective use of Roche delivery frameworks such as SPEED, and promotes automation, traceability, and quality engineering practices that enable scalable, compliant reuse.
Qualifications
Education / Experience
Extensive experience leading strategic, cross-functional initiatives in clinical data, data standards, metadata, master data, or informatics within pharma, biotech, or another regulated environment.
Proven experience defining or operationalizing CDISC standards (e.g., CDASH, SDTM, ADaM, Define-XML and controlled terminology) and embedding them into business processes, governance, and technology solutions.
Strong track record partnering across business and IT to shape domain roadmaps, data governance models, operating practices, and supporting technologies for standards and master data at scale.
Experience overseeing delivery of business-critical data or metadata platforms, including vendor or partner governance, release planning, issue escalation, service health monitoring, and coordination across matrixed teams.
Technical Skills
Deep knowledge of clinical data standards, including CDISC standards, controlled terminology, metadata management, standards lifecycle management, and traceability from collection through analysis and submission.
Strong expertise in semantic modelling, including canonical data models, ontology and knowledge representation concepts, and semantically enriched metadata structures that enable interoperability and machine-readable data assets.
Solid understanding of master data and reference data management principles, including stewardship, data quality controls, hierarchies, versioning, lineage, and change management.
Experience working with data integration patterns, APIs, metadata repositories, cloud data platforms, or graph and semantic technologies, with the ability to translate domain needs into scalable technology requirements.
Ability to establish KPI dashboards and structured tracking for milestones, incidents, defects, dependencies, and operational risk, and to use those insights to drive accountable delivery across internal teams and external partners.
Familiarity with quality engineering and compliance practices such as automated testing, audit trails, change control, access governance, and management of technical debt or non-functional requirements in GxP-relevant environments.
Additional Qualifications
Exceptional stakeholder management and communication skills, with the ability to influence senior leaders, mentor peers, and build strong Communities of Practice while driving accountable execution across matrixed and multi-partner teams; experience in clinical development, regulatory data flows, or AI-ready data foundations is highly desirable.
Demonstrated ability to drive proactive onboarding, offboarding, and knowledge-transfer practices that reduce delivery risk and strengthen long-term maintainability of standards and master data platforms.
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