Job Title: Signal Manager
• Location: Hyderabad
About the job
Join our Monitoring Excellence team and be part of a transformative journey in clinical trial oversight. Data-Driven Monitoring (DDM) redefines the way monitoring activities are conducted by shifting from traditional fixed schedules and subjective assessments to a dynamic, data-driven decision model — grounded in workload estimation and risk evaluation. This forward-thinking approach considers both current and future states of monitoring activities, enabling smarter, faster, and more effective oversight across clinical trials.
The Signal Manager is responsible for managing the workload and quality dashboard via the DDM Tool, assessing signals for assigned study(ies) from RBM kick-off to database lock. You will drive and cooperate with the local team to implement an adaptive monitoring strategy and facilitate the efficient and effective performance of the site monitoring activities. An exciting data-driven role which has lots of scope for growth and development.
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:
• Monitoring Coordination: Develop and maintain site monitoring schedules tailored to each site's risk profile and workload, collaborating closely with the Central Monitor to seamlessly coordinate on-site and remote monitoring activities for optimal coverage and efficiency.
• Risk Signal Assessment: Proactively identify, analyze, and interpret risk signals within the quality dashboard at the site level, translating data insights into clear, actionable recommendations presented to Site Monitors (SMs) in full adherence to Sanofi protocols and standards.
• Risk Escalation & Tracking: Promptly escalate identified risks or issues to relevant stakeholders — including the Central Monitor and Site Monitors — ensuring transparent communication and diligent follow-through until full resolution is achieved.
• Risk-Based Strategy Support: Partner with the Central Monitor to define and refine a tailored risk-based monitoring strategy for each assigned study, ensuring alignment with Sanofi's quality objectives and applicable regulatory requirements.
• Monitoring Strategy Enhancement: Collaborate closely with the Local Study Team to continuously strengthen and adapt the monitoring strategy, driving improvements that reflect evolving study needs and site dynamics.
• Data-Driven Monitoring Integration: Support the evolving Data-Driven Monitoring (DDM) and RBM (Risk Base Monitoring) framework, contributing to the optimization of monitoring approaches within the broader DDM ecosystem.
About you
• 2+ years of experience in trial operation, Central Monitoring, data management or quality management
• Understanding clinical research regulatory requirements, including ICH GCP guidelines.
• Proficiency in data analysis and providing actionable insights.
• Project management skills.
• Be able to learn and adapt quickly.
• Good interpersonal, communication, and presentation skills.
• Trial ops experience including CTA, CRA, Central Monitor, CDC, Clinical Study Data Manager, Clinical Project manager, Associate or Global Study Managers, QA, or Clinical project-related role.
• MS Office- Excel, Word, PowerPoint & SharePoint
• Able to review or learn to use the business intelligence dashboard.
• Bachelor’s degree or above, preferably in life science (or equivalent)
• 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.
• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• A team that drives the innovation of monitoring activities that align with future needs
“Our Signal Manager is a pivotal player in our team, entrusted with the responsibility to assess workload and mitigate risks for monitoring strategy, using cutting-edge methodologies and tools. This position is the blend of deep analytical skills, strategic thinking, and the opportunity to directly influence the quality and reliability of our clinical data”
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 and check out our Diversity Equity and Inclusion actions at sanofi.com!