Principal Study Data Manager
Hyderabad
Sanofi
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives.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
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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Data management GCP
Perks/benefits: Career development Equity / stock options Health care Medical leave Parental leave Wellness
More jobs like this
Explore more AI, ML, Data Science career opportunities
Find even more open roles in Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), Computer Vision (CV), Data Engineering, Data Analytics, Big Data, and Data Science in general - ordered by popularity of job title or skills, toolset and products used - below.
- Open Research Scientist jobs
- Open Data Science Manager jobs
- Open Data Engineer II jobs
- Open Principal Data Scientist jobs
- Open Business Data Analyst jobs
- Open Data Scientist II jobs
- Open BI Analyst jobs
- Open Sr Data Engineer jobs
- Open Business Intelligence Engineer jobs
- Open Lead Data Analyst jobs
- Open Sr. Data Scientist jobs
- Open Data Science Intern jobs
- Open Software Engineer, Machine Learning jobs
- Open Senior Business Intelligence Analyst jobs
- Open Junior Data Scientist jobs
- Open MLOps Engineer jobs
- Open Azure Data Engineer jobs
- Open Manager, Data Engineering jobs
- Open Data Analytics Engineer jobs
- Open Marketing Data Analyst jobs
- Open Data Engineer III jobs
- Open Junior Data Engineer jobs
- Open Data Analyst II jobs
- Open Data Engineering Manager jobs
- Open ETL Developer jobs
- Open Data quality-related jobs
- Open Tableau-related jobs
- Open Privacy-related jobs
- Open Excel-related jobs
- Open ML models-related jobs
- Open Data pipelines-related jobs
- Open APIs-related jobs
- Open PhD-related jobs
- Open PyTorch-related jobs
- Open Finance-related jobs
- Open Data visualization-related jobs
- Open LLMs-related jobs
- Open Consulting-related jobs
- Open TensorFlow-related jobs
- Open Deep Learning-related jobs
- Open Business Intelligence-related jobs
- Open Generative AI-related jobs
- Open CI/CD-related jobs
- Open NLP-related jobs
- Open Data governance-related jobs
- Open DevOps-related jobs
- Open Kubernetes-related jobs
- Open Git-related jobs
- Open Hadoop-related jobs
- Open Docker-related jobs