Responsible for the oversight of risk management activities on a portfolio of clinical projects in accordance with ICH GCP E6 requirements.
The Clinical Risk Lead will coordinate the development of project specific risk assessments, risk management plans and Integrated Strategic Monitoring Plans (ISMPs) during study start up whilst driving compliance to these plans throughout the project lifecycle.
The Clinical Risk Lead will maintain the risk library and provide guidance to ensure consistency within the organization in terms of risk assessment and management.
The Clinical Risk Lead will assist in the development of the clinical monitoring strategy, and the application of RBQM principles to other functional plans in collaboration with other functional leads and, where required, will develop and deliver training to the study team regarding the risk assessment and the clinical monitoring strategy.

The successful candidate will possess a minimum of an undergraduate degree and 4-6 years of relevant experience (including a minimum of 3 years in clinical trials), with knowledge and prior experience of Risk Based Quality Management concepts.
The ideal candidate will be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
The Clinical Risk Lead should demonstrate the following attributes: proactive, detail oriented, critical thinker, task-driven and highly organized.
The candidate should also be able to demonstrate the critical elements of GCPs and local regulations, be capable of working in a global environment and a cross-functional team, as well as the ability to apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical trial.

Clinical Risk Lead

Key skills