Principal Study Data Manager

Job title: Principal Study Data Manager

• Location:IN / Hyderabad
  

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 Principal 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?

Major Responsibilities:

• 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.

• Identifications of areas for continuous improvement and active participation or leadership of transformation initiatives.

About you

• Experience: 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.

• Soft and technical skills: 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.

• 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 and AI Based automations is a plus

• Education : Bachelor’s degree or above, preferably in a life science or drug development related field.

• Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Join an international innovative biopharma company.

• Participate in the evolution of Clinical Data Management and deployment of innovations