Central Risk Manager (Risk based Central Monitoring)

Overview

Central Risk Manager responsible for risk-based central monitoring strategy, risk assessment deliverables, and guidance across cross-functional study teams.

What you'll do

• Advise on the development of the project monitoring strategy and updates during the study based on risks.
• Work with cross-functional leads to understand complex indications and risks and guide risk mitigations.
• Draft the initial risk assessment and support cross-functional involvement in finalizing the RACT.
• Support PL transfers of identified risks to the correct tracking system and enable ongoing cross-functional risk review.
• Assess tools for remote data review and centralized statistical monitoring to identify risks to data quality and integrity.
• Facilitate review of findings with internal cross-functional teams and the sponsor.

What you'll need

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
• Expertise in Good Clinical Practice/ICH E6 (R2) and/or other applicable regulatory requirements.
• Expertise in Risk-Based Monitoring Strategies processes and tools (preferred).
• Expertise in Integrated Quality Risk Management (IQRM) theories.
• Mastery of MS Excel (sorting, filtering, calculating, pivoting).
• Knowledge of statistical analysis techniques, visualizations and tools (e.g., Cluepoints, Medidata-CSA, Funnel Plots, Box and Whiskers).

Details

• Work location: IND-Remote.