Lead Clinical Risk Management Analyst

The Lead Clinical Risk Management Analyst is responsible to lead and manage the development, documentation, and execution of risk-based quality management process, as described in the risk assessment, data management plan, and site and central monitoring plans.

• Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies
• Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality
• Facilitate multi-stakeholder discussions to facilitate review findings, evaluate impact and develop action plans for correction and continued monitoring
• Conduct or facilitate Central Monitoring activities, as described in Central Monitoring Plan
• Facilitate data cleaning activity related to assigned studies as needed

• Bachelor’s degree in life sciences, medical, bio-medical engineering, or related field
• Minimum 6 years in clinical research or related field
• Education and work experience in research compliance, or quality, project management, or life sciences or clinical research
• Knowledge of data collection best practices for clinical trials familiarity with regulatory frameworks (e.g., FDA, EMA, ICH-GCP)
• Knowledge of global clinical research operations

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.