Job title: Principal Data Intergration Analyst

• Location: IN / Hyderabad
• Grade: L2-2
  

About the job

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 Principal Database Integration Analyst within our Hyderabad Hub, you will lead the integration of data collected through clinical trials, playing a pivotal role in implementing tools to enhance data flow management. Your responsibilities will include 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:
1. 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.
2. Leading study data integration activities for the data flow implementation with external providers and internal: specifications, implementation, testing including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, HR and mobile healthcare.
3. 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.
4. Proactively anticipating and remediating data integration issues arising during study conduct and monitoring them until resolution.
5. Identifications of areas for continuous improvement and active participation or leadership of transformation initiatives.
6. Analysing new requirements from customer and propose technical solution strategies.
7. Serve as an expert for specific data flows implementation to coach new Data integration Analyst.

About you
• Experience: Experience in clinical data management and more than 2 years in external data integration and mapping.
• Soft and technical skills: Advanced 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
• Strong knowledge in data transfer and data mapping using digital tools.
• Strong project management skills and experience. 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.