**Job title: Senior Study Data Manager** **_Location:_** **_IN / Hyderabad_** **_About the job_** 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. 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 **Senior Study Data Manager** within our Clinical Data Management, you’ll be accountable for the quality of CDM deliverables and for ensuring accurate and reliable study data, therefore guaranteeing the reliability of the study results. The employee ensures activities are completed according to agreed standards and timelines. The employee 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. **_About you_** + **Experience:** experience on clinical data management and must have been in a project management role. + **Soft skills:** Strong project management skills and experience. Anticipate delivery risks. + Learn and adapt quickly when facing new problems. + Good interpersonal, communication, and presentation skills. + **Technical skills:** 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. + 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. + Join an international innovative biopharma company. + Participate in the evolution of Clinical Data Management and deployment of innovations. **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)