Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Senior Data Integration Analyst within our Hyderabad Hub, you will play a key role in the integration of data collected through clinical trials, contributing significantly to implementing tools to enhance data flow management. Your responsibilities will include the implementation of data flows and data mapping to meet the organization's clinical data hub standards and ensuring compliance with GCP and applicable regulatory guidelines. You will ensure that all activities are completed according to agreed-upon standards and timelines, while also providing support to guarantee the accuracy and reliability of the data.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities:
Supporting the quality of CDM data integration deliverables (such as FTS (File Transfer Specification), DTA (Data Transfer Agreement), Data Mapping specification and implementation) to ensure the delivery of accurate and reliable clinical study data.
Assisting in 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.
Coordinating with internal customers (Clinical Data Manager, Global Study Manager, Study Medical Manager, Statistician, Quality, etc.) and external providers to support clinical data integration activities for studies and discussing timelines.
Proactively identifying and helping to resolve data integration issues arising during study conduct and monitoring them until resolution.
Contributing to identifying areas for continuous improvement and participating in transformation initiatives.
Supporting the analysis of new requirements from customers and assisting in proposing technical solution strategies.
• Experience: Experience in clinical data management and knowledge external data integration and mapping.
• Soft and technical skills: Collaboration and communication skill
• Experience with CDM and related regulations (incl. ICH E6 and E8).
• 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.
• Knowledge in CDISC standards /terminologies in Clinical Data Standards. 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.
• Education: 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).
• Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!