Signal Manager

Job title: Signal Manager

• Location: IN / Hyderabad

About the job

An exciting opportunity to join our risk-based monitoring team. Risk-based monitoring (RBM) is an adaptive approach to clinical trial monitoring that directs focus and activities to critical data and processes that have the most potential to impact patient safety and data quality. In this context, the RBM team is responsible for designing, executing, and optimizing the Sanofi RBM approach to align with regulatory requirements and Sanofi's objective to drive quality, efficiency, and speed of clinical trials.

The Signal Manager is responsible for managing the RBM signal-related activities for assigned study(ies) from RBM kick-off to database lock. You’ll bring insights through analyzing the clinical and operational data to ensure data quality, patient safety, and trial results reliability. You will also 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:

• Study Risk-Based Monitoring Strategy Execution: Implement the study's RBM strategy and operationalize Quality Tolerance Limits (QTLs), focusing on analysis scope, schedule, and methodology in line with Sanofi's standards and study timelines.

• Monitoring Coordination: Develop site monitoring schedules tailored to site risk and workload profile, collaborating with the central monitors to coordinate on-site and remote monitoring activities.

• Generate the risk signal: Oversee Key Risk Indicators (KRIs), Data Quality Assessments (DQAs), and QTLs to identify and analyze risk signals at the site, country, and study levels. Propose and present corrective actions to the CentralMonitor (CM), adhering to Sanofi protocols.

• Risk Escalation and Tracking: Promptly escalate identified risks or issues to pertinent stakeholders, including the Central Monitor and Site Monitor, and diligently track these until they are resolved.

• Risk-Based Strategy Support: Assist the Central Monitor in defining a tailored risk-based strategy for each assigned study, aligning with Sanofi's objectives and regulatory requirements.

About you

• Experience: Experience in trial operation or data management or quality management.

• Familiarity with clinical research regulatory requirements, including ICH GCP guidelines.

• Proficiency in data analysis and providing actionable insights.

• Soft and technical skills: Project management skills.

• Be able to learn and adapt quickly.

• Good interpersonal, communication, and presentation skills.

• Trial ops experience including CTA, CRA, CDC, Clinical Study Data

• Managers, Project managers, Associate or Global Study

• Managers, QA, or Clinical project-related

• MS Office- Excel, Word, PowerPoint & SharePoint

• Able to review or learn to use the business intelligence dashboard.

• Education: Bachelor’s degree or above, preferably in life science (or equivalent)

• 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.

• 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 the monitoring activities that align with future need

“Our Signal Manager is a pivotal player in our team, entrusted with the responsibility to detect and mitigate risks, 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”