Risk Manager (Clinical Research)
Core
Develop and implement risk-based monitoring strategies to protect clinical trial quality, data integrity, and operational effectiveness.
Role type
Senior Risk Manager (Clinical Research)
Builds
Risk assessment frameworks, mitigation plans, and centralized monitoring reports for clinical trials
Domain
Clinical Research / Pharmaceutical Industry
Required skills
Risk-Based Monitoring (RBM) strategies, Good Clinical Practice (GCP), ICH E6 guidelines, regulatory compliance (FDA/Health Canada), centralized data review, statistical analysis, project management, training and mentoring
Preferred skills
Lean Six Sigma, RACT tools, trial management systems, data management systems
Technologies
Microsoft Excel, RACT tools, trial management systems, data management systems
Responsibilities
Develop and update risk-based monitoring strategies; Collaborate with cross-functional teams to identify and mitigate risks; Coordinate with central monitoring teams; Draft risk assessments and complete RACT tools; Guide project managers on risk tracking; Deliver training on risk assessment and monitoring approaches; Escalate identified risks and at-risk deliverables; Provide strategic insights to leadership
Seniority
Senior, hands-on IC