Risk Manager (Clinical Research)-Poland
Core
Develop and execute risk-based monitoring strategies to ensure data quality and integrity in clinical research projects.
Role type
Senior IC Risk Manager (Clinical Research)
Builds
Risk assessments, monitoring strategies, and risk mitigation plans for clinical trials
Domain
Clinical Research / Pharma / CRO
Required skills
Risk-Based Monitoring (RBM), Good Clinical Practice (GCP)/ICH E6, data quality assurance, cross-functional collaboration, budget management, risk assessment tools (RACT), analytical data visualization, MS Excel, Lean Six Sigma, clinical trial protocols
Preferred skills
Centralized statistical monitoring, trial management systems, regulatory knowledge (FDA/Health Canada)
Technologies
RACT tools, MS Excel, analytical data visualization tools, trial management systems
Responsibilities
Develop risk-based monitoring strategies, identify and mitigate risks across the clinical trial lifecycle, coordinate with central monitor teams, draft risk assessments, guide Project Managers on risk tracking, conduct remote data reviews, deliver training on risk strategies, escalate risks to leadership
Seniority
Senior, hands-on IC