Sanofi Hiring Signal Manager

Sanofi want to build a healthier, more resilient world. We turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Post : Signal Manager

Job Description
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.

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.

Candidate Profile
• 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.

Additional Information
Qualification : Bachelor’s degree or above, preferably in life science
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th July 2024