Clinical Risk Analyst Mgr.

Career Category

Clinical Development

Role Description:

The Clinical Risk Analyst is responsible for generating and translating study-level risk insights to enable proactive, data-driven decision-making across the conduct of clinical trials. This role is a key driver of Risk-Based Quality Management (RBQM), leveraging centralized monitoring, analytics, and cross-functional data sources to identify, assess, and mitigate risks to patient safety, data integrity, and study delivery.

Working closely with Study Delivery Teams, Central Monitors, and cross-functional stakeholders, the Clinical Risk Analyst leads structured risk review processes, ensuring that risks are identified early, understood in clinical and operational context, and addressed through clear, actionable mitigation strategies.

The role plays a critical part in connecting study-level risk signals to broader program and portfolio risk perspectives, maintaining a strong partnership with Associate Directors of Risk Management to ensure visibility, alignment, and aggregation of emerging trends. Through this, the Clinical Risk Analyst contributes to continuous improvement of risk models, monitoring approaches, and overall study execution quality.

Roles & Responsibilities:

• Lead centralized monitoring reviews using platforms such as CluePoints to drive risk identification, signal detection, trend analysis, and structured decision-making across assigned studies.

• Define, implement, and continuously refine Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), including thresholds, triggers, and escalation pathways aligned to study critical-to-quality factors.

• Provide expert input into Study Risk Assessments (SRA) during study start-up and contribute to the development of risk review strategies within the Integrated Data Review Plan (IDRP).

• Critically evaluate centralized monitoring outputs to distinguish true risk signals from noise, incorporating clinical and operational context to identify root causes and recommend appropriate mitigation actions.