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Global drug and device development services

Risk Based Study Management Lead

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in UK

About the Job

Requirements

  • Experience in clinical trial operations, study management, monitoring, or centralized oversight.
  • A solid understanding of risk-based monitoring and study management principles.
  • Knowledge of ICH-GCP, regulatory standards, and quality frameworks.
  • Strong facilitation skills and confidence leading cross-functional discussions.
  • An analytical mindset and ability to interpret data, trends, and signals.
  • Excellent communication and stakeholder management skills.
  • Ability to work independently while collaborating effectively with sponsor and ICON teams.
  • Legal right to work in the country where the role is based.

Responsibilities

  • Lead and maintain study-level risk assessments for assigned sponsor studies.
  • Facilitate and chair cross-functional risk review meetings, focusing on critical data and processes.
  • Drive proactive identification, discussion, and documentation of study risks.
  • Partner with the Clinical Research Manager and study team to ensure aligned oversight and follow-through on mitigation actions.
  • Review centralized monitoring outputs, key risk indicators, key performance indicators, and trends to detect emerging or systemic risks.
  • Support issue escalation, root cause analysis, and risk mitigation planning.
  • Ensure risk-based activities align with established principles and sponsor expectations.
  • Contribute to inspection readiness through clear documentation and defensible oversight decisions.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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