Senior Study Data Manager

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

Within the Clinical Trial Team (CTT), the Senior Study data manager is responsible for leading the end-to-end Clinical Data Management (CDM) activities and study deliverables supporting study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. He / She is accountable for the quality of CDM deliverables and for ensuring accurate and reliable study data, therefore guaranteeing the reliability of the study results. He / She ensures activities are completed according to agreed standards and timelines. He / She provides comprehensive CDM expertise and supports team members by coordinating cross functional data related activities globally to ensure the flawless conduct of a clinical trial.

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 Include

• Accountability for the quality of CDM deliverables (such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings / Reports / Visualizations) and for the delivery of accurate and reliable clinical study data.
• Liaising directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all CDM activities for studies, discussing timelines, and providing CDM updates.
• Proactively anticipating and remediating CDM issues arising during study conduct and monitoring them until resolution.
• Defining and implementing data cleaning & validation strategy integrating risk-based approaches.
• Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, and other review activities during the conduct of a study.
• Leading study activities with internal and external (e.g., Providers) CDM delivery teams (Database Developers, Data Management Programmers, Central Monitors, etc.) and mentoring new Study Data Managers.
• Coordinating all external data activities : specifications, loading and reconciliation, including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare.

About You

Why choose us

'Sanofi is at the forefront of the Clinical Data Management Modernization. Our ambitions are significant but pragmatic. The speed of change unprecedented but achievable. Join us of you want to help us transform our vision into a reality!' Patrick Nadolny, Global Head of Clinical Data Management and Chair of the Board at the Society for Clinical Data Management (SCDM).

null Pursue Progress . Discover Extraordinary .

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives Let's Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Skills Required

Centralized Monitoring Plan, Visualizations, AI Based automations, Data Validation Specifications, Data Management Plan, ICH E6, Risk-based approaches, eSource, Data Review Listings, Master Adaptive Protocols