Responsible for the oversight of risk management activities on a portfolio of clinical projects in accordance with ICH GCP E6 requirements
Coordinate the development of project-specific risk assessments, risk management plans, and Integrated Strategic Monitoring Plans (ISMPs) during study startup
Drive compliance to these plans throughout the project lifecycle
Maintain the risk library and provide guidance to ensure consistency within the organization in terms of risk assessment and management
Assist in the development of the clinical monitoring strategy, and the application of RBQM principles to other functional plans
Develop and deliver training to the study team regarding the risk assessment and clinical monitoring strategy

Requirements

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)
Knowledge and prior experience of Risk Based Quality Management concepts
Proficient with MS Office
Strong written and verbal communication skills
Highly effective interpersonal and organizational skills
Proactive, detail-oriented, critical thinker, task-driven, and highly organized
Capable of working in a global environment and a cross-functional team
Ability to apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical trial.

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

risk managementrisk assessmentsrisk management plansIntegrated Strategic Monitoring Plansclinical monitoring strategyRisk Based Quality Management

Soft Skills

written communicationverbal communicationinterpersonal skillsorganizational skillscritical thinkingdetail-orientedtask-driven