Signal Manager

Job title: Signal Manager

• Location: Hyderabad, India
• Notice Period : Immediate Joiners

Must-Have Skills :

• Risk-Based Monitoring (RBM)
• Centralized Monitoring
• Clinical Data Analysis

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 peoples lives. Were 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 our 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 our 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 :

Experience:

• 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.

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, 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.

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.

Interested Candidates can apply

Email : [email removed]

Whatsapp : [phone removed]

Thanks & Regards,

Manpower Group