Senior Data Integration Analyst

Overview

Senior Data Integration Analyst within the Hyderabad Hub, responsible for integrating clinical trial data, implementing data flows and data mapping to meet clinical data hub standards, and ensuring GCP and regulatory compliance.

What you'll do

• Be accountable for the quality of CDM data integration deliverables (such as FTS, DTA, data mapping specifications and implementation) and for the delivery of accurate and reliable clinical study data.
• Coordinate study data integration activities for data flow implementation with external providers and internal stakeholders, including specifications, implementation and testing, covering data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, HR and mobile healthcare.
• Liaise 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 and discuss timelines.
• Proactively anticipate and address data integration issues arising during study conduct and monitor them until resolution.
• Identify areas for continuous improvement and actively participate in them.
• Analyze new requirements from customers and propose technical solution strategies.
• Provide support in the implementation of specific data flows and offer assistance to new Data Integration Analysts.

What you'll need

• At least 3 years' experience in clinical data management.
• More than 1 year in external data integration and mapping.
• Good collaboration and communication skills.
• Strong experience with CDM and related regulations (including ICH E6 and E8).
• Solid risk-based mindset focusing on Quality by Design (QbD) and on what really matters.
• Ability to learn and adapt quickly when facing new problems.
• Ability to think critically and use rigorous, objective and pragmatic methods to solve multidimensional problems with effective and timely solutions.
• Experience with CDISC standards/terminologies in clinical data standards.
• Good knowledge of data transfer and data mapping using digital tools.
• Ability to 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, and eSource.
• 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), with the ability to communicate fluently in a global environment.

Nice to have

• Programming languages (SAS, R or Python) and AI-based automations.

Details

• Location: Hyderabad.