Overview

As the lead for the Clinical Data Platform, you define the target-state architecture and governance that enable AI-ready analytics and end-to-end transparency in general clinical development. You drive the evolution of the data repository and harmonize data flows across the R&D; ecosystem. Partnering with Clinical Operations, Data Management, Biometrics, Regulatory, and Quality, you deliver scalable, compliant data solutions on a cloud-native, AI-enabled platform. You influence how clinical insights are generated and acted upon to accelerate life-changing therapies.

Responsabilidades

- Own the architectural vision and governance roadmap for the Clinical Data Platform
- Define target-state architecture for clinical and operational study data
- Lead modernization of the Operational Data Repository with data product concepts
- Drive harmonized, scalable data flows across the R&D; ecosystem
- Shape integration architecture connecting EDC, eTMF, and CTMS
- Ensure data integrity, security, and GxP compliance
- Partner with Clinical Operations, Data Management, Biometrics, Regulatory, Quality, and Technology teams
- Translate complex data challenges into innovative,



future-proof solutions on a cloud-native AI-enabled platform
- Influence how clinical insights are generated and used to accelerate development

Requisitos principales

- 10+ years in clinical development, clinical data architecture, data management, or clinical technology
- Deep expertise in clinical trial data domains (CTMS, EDC, eTMF, study/site/subject/operational data)
- Strong knowledge of Good Clinical Practice, GxP, CDISC standards, data governance, and lifecycle management
- Hands-on experience with cloud-native platforms and data stack technologies (AWS, Snowflake, dbt)
- Ability to define data strategy and influence senior stakeholders; strong communication across scientific and business audiences
- Proficiency in AI/ML concepts, with awareness of ethical and regulatory considerations
- Fluent in English; German is advantageous

- cross-functional collaboration
- stakeholder influence
- clear communication
- clinical trial data domains (CTMS, EDC, eTMF)
- CDISC standards
- GxP compliance

📌 Functional Data Architect R&D Clinical Operations - mollet del vallés (Mollet del Vallès)
🏢 Merck
📍 Mollet del Vallès