Clinical Data Standards and Master Data Digital Solution Lead

Digital Solution Lead

As a Digital Solution Lead, you will spearhead the strategy, operating model, and delivery governance for Clinical Data Standards, Master Data, and the supporting technology ecosystem. You will partner with cross-functional teams to ensure clinical data is defined, governed, and delivered reliably. This role requires deep expertise in CDISC and semantic modelling to build interoperable, metadata-driven foundations.

Responsibilities

• Lead domain vision for Clinical Data Standards and Master Data, shaping cross-functional strategy and delivery models.
• Resolve complex issues regarding data standards adoption, metadata definition, and technology integration.
• Build trusted partnerships across PD Data Sciences, Clinical Data Management, Biostatistics, and IT stakeholders.
• Define and drive the roadmap for clinical standards and master data capabilities, including in-house platforms like GDSR and Lynx.
• Manage ambiguity across regulatory expectations, business priorities, and technical constraints.
• Combine business consulting with technical fluency in CDISC, semantic modelling, and metadata-driven architecture.

Requirements

• Extensive experience leading strategic, cross-functional initiatives in clinical data, data standards, or informatics within a regulated environment.
• Proven experience operationalizing CDISC standards (CDASH, SDTM, ADaM, Define-XML) and embedding them into business processes.
• Strong track record of partnering across business and IT to shape domain roadmaps and data governance models.
• Deep knowledge of semantic modelling, canonical data models, and master/reference data management principles.
• Experience with data integration patterns, APIs, metadata repositories, and cloud data platforms.
• Exceptional stakeholder management and communication skills with the ability to influence senior leaders and drive accountable execution.