Study Data Manager (Early Phase)

Job title: Study Data Manager

• Location:IN / Hyderabad

• Grade:  L1-2

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. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Study Data Manager within our CDM Group.

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 Duties and 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.

• 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

Experience: Experience on clinical data management of which 1 years must have been in a project management role.

Soft Skills: Project management skills and experience.
Learn and adapt quickly when facing new problems.
Good interpersonal, communication, and presentation skills.
Technical skills:  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.
Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment.

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

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.