Clinical Risk Lead
AlimentivManchester
On-site Full-time
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Experience Level
Experience
Qualifications
Ideal candidates will possess a strong background in clinical research, with experience in risk management and compliance within clinical project environments. A thorough understanding of ICH GCP E6 requirements is essential. Excellent communication and coordination skills are required to work effectively with multidisciplinary teams. Candidates should also demonstrate a proactive approach to risk assessment and management, along with the ability to develop and implement training programs for study teams.
The Clinical Risk Lead plays a pivotal role in overseeing risk management activities across a diverse portfolio of clinical trials, ensuring compliance with ICH GCP E6 standards. This position involves the coordination of project-specific risk assessments, risk management plans, and Integrated Strategic Monitoring Plans (ISMPs) during the start-up phase of studies. The Clinical Risk Lead is also tasked with maintaining the risk library and providing essential guidance to ensure consistency in risk assessment and management practices across the organization. In addition, this role will contribute to the development of clinical monitoring strategies and the application of Risk-Based Quality Management (RBQM) principles by collaborating with other functional leaders. Training will be delivered to study teams regarding risk assessments and clinical monitoring strategies to ensure a comprehensive understanding of these critical components.
About Alimentiv
Alimentiv is a leading provider of specialized clinical research services, dedicated to advancing healthcare through innovative solutions. Our team is committed to delivering excellence and ensuring the highest standards in clinical trial management.
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