Senior Data Integration Analyst

• Accountability for the quality of CDM data integration deliverables (such as FTS (File Transfer Specification), DTA (Data Transfer Agreement), Data Mapping specification and implementation) and for the delivery of accurate and reliable clinical study data.
• Coordinating study data integration activities for the data flow implementation with external providers and internal stakeholders: specifications, implementation, testing including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, HR, and mobile healthcare.
• Liaising directly with internal customers (Clinical Data Manager, Global Study Manager, Study Medical Manager, Statistician, Quality, etc.) and external providers to coordinate all clinical data integration activities for studies and discussing timelines.
• Proactively anticipating and addressing data integration issues arising during study conduct and monitoring them until resolution.
• Identifying areas for continuous improvement and actively participating.
• Analyzing new requirements from customers and proposing technical solution strategies.
• Providing support in the implementation of specific data flows and offering assistance to new Data Integration Analysts.

• At least 3 years’ experience in clinical data management and more than 1 years in external data integration and mapping.
• Good collaboration and communication skill. Strong experience with CDM and related regulations (incl. ICH E6 and E8).
• Solid risk-based mindset focusing on Quality by Design (QbD) and on what really matters.
• Learn and adapt quickly when facing new problems. Think critically and use rigorous, objective, and pragmatic methods to solve multidimensional problems with effective and timely solutions.
• Experienced in CDISC standards /terminologies in Clinical Data Standards. Good knowledge in data transfer and data mapping using digital tools.
• Anticipate delivery risks, bottlenecks, issues, and delays to proactively prevent them or minimize their impact.
• Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource. Programming languages (SAS, R or Python) and AI Based automations is a plus.
• Bachelor or Master of Science degree or above, preferably in a life science or mathematics-related area (e.g., Pharmaceutical, medical, or mathematics, computer science or similar technical fields).
• Strong English skills (verbal and written), ability to exchange fluently in a global environment.

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