RBM Site Monitoring Lead

ICON plc

4d • Remote

About The Position

RBM Monitoring Lead ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Clinical Trial Manager at ICON, you will manage clinical trial operations activities, supporting your team and stakeholders to deliver high-quality outcomes across our clinical programmes.

Requirements

• Solid clinical trial management experience, with the ability to manage competing priorities and develop your team.
• University degree in medicine, science, or equivalent combination of education & experience.
• Demonstrated ability to drive the clinical deliverables of a study.
• Minimum of 6 years of experience in the pharmaceutical or CRO industry.
• Minimum of 2 years of experience in Site Monitoring / Site Monitoring Management, Risk-Based Monitoring, or Monitoring Excellence roles.
• Robust understanding of drug development and clinical trial execution processes.
• Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP).
• Willingness to travel as required (approximately 25%).
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes.
• Lead RBM strategy meetings and develop study-specific site monitoring plan, aligned with study risk assessment; includes SDV and SDR strategies as well as site monitoring mitigations and end-to-end site monitoring requirements for the study.
• Ensure monitoring strategies are configured in technology capabilities (e.g., TSDV).
• Manage Site Monitoring assignments in client's systems (e.g., CDMS, CTMS).
• Provide Site Monitoring training (on RBQM and client's systems, as well as study materials) and support the creation and delivery of initial and ongoing site monitoring materials (e.g., annotated monitoring visit reports etc.) and training.
• Serve as primary reviewer of site monitoring visit reports, ensuring reports meet client's expectations; escalates issues of concern to Clinical Study Manager.
• Review systems and dashboards to assess site monitoring compliance (e.g., IMV frequency); triages site monitoring requests from other functional teams, and manages action items in client's CTMS.
• Support site monitoring needs during study conduct, including triggering monitoring visits, assessing co-monitoring or multi-day visit requests.
• Provide site management back-up as needed while Site Monitors are conducting site monitoring visits.
• Trigger and manage or conduct Monitoring Oversight Visits to assess site monitoring quality and/or resolve issues in site data quality or site monitoring quality.
• Partner with RBQM Operations team to address unresolving centralized monitoring findings with sites; support sites and site monitors in RBQM processes.
• Perform periodic assessment of site monitoring / RBM compliance KPIs and KQIs, providing summaries to Study Management and other key stakeholders.
• Maintain up-to-date, accurate documentation of Site Monitoring activities / deliverables; serve as a study-level CRO counterpart for site monitoring activities.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Senior