Risk Based Site Management Lead

The Role

As a Risk‑Based Study Management Lead, you will provide end‑to‑end risk oversight for assigned clinical studies, ensuring risks to patient safety, data quality, and trial integrity are proactively identified, discussed, and managed throughout the study lifecycle.

You will work in close partnership with the Clinical Research Manager (CRM) and broader study team, facilitating risk‑focused discussions and driving clear, practical mitigation strategies.

This role can be based anywhere in the UK.

Key Responsibilities

• Lead and maintain study‑level risk assessments for assigned sponsor studies

• Facilitate and chair cross‑functional risk review meetings, ensuring focus on critical data and processes

• Drive proactive identification, discussion, and documentation of study risks

• Partner closely with the CRM and study team to ensure aligned oversight and follow‑through on mitigation actions

• Review centralized monitoring outputs, KRIs, KPIs, and trends to detect emerging or systemic risks

• Support issue escalation, root cause analysis, and risk mitigation planning

• Ensure risk‑based activities align with set principles and sponsor expectations

• Contribute to inspection readiness through clear documentation and defensible oversight decisions

What You Bring

• Experience in clinical trial operations, study management, monitoring, or centralized oversight

• Solid understanding of risk‑based monitoring and study management principles

• Knowledge of ICH‑GCP, regulatory standards, and quality frameworks

• Strong facilitation skills with confidence leading cross‑functional discussions

• Analytical mindset with the ability to interpret data, trends and signals

• Excellent communication and stakeholder management skills

• Ability to operate independently while collaborating effectively with sponsor and ICON teams