RBM Site Monitoring Lead

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.

What You Will Do:

You will manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes.

Key responsibilities include: Leads RBM strategy meetings and develops 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  

Ensures monitoring strategies are configured in   technology   capabilities (e.g., TSDV)  

Manages Site Monitoring assignments in client's systems (e.g., CDMS, CTMS)  

Provides Site Monitoring training (on RBQM and client's systems, as well as study materials) and supports the creation and delivery of   initial   and ongoing site monitoring materials (e.g., annotated monitoring visit reports etc.) and training  

Serves as primary reviewer of site monitoring visit reports, ensuring reports meet client's expectations; escalates issues of concern to Clinical Study Manager   

Reviews 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.   

Supports site monitoring needs during study conduct, including triggering monitoring visits, assessing co- monitoring   or multi-day visit requests. Provides site management back-up as needed while Site Monitors are conducting site monitoring visits.  

Triggers and manages or conducts Monitoring Oversight Visits to assess site monitoring quality and/or resolve issues in site data quality or site monitoring quality.  

Partners with RBQM Operations team to address unresolving centralized monitoring findings with sites; supports sites and site monitors in RBQM processes.  

Performs periodic assessment of site monitoring / RBM   compliance   KPIs and KQIs, providing summaries to Study Management and other key stakeholders.   

Maintains up-to-date,   accurate   documentation of Site Monitoring activities / deliverables; serves as a study-level CRO counterpart for site monitoring activities.   

Your Profile:

You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience: 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.

Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include: 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request  here .

Are you a current ICON Employee? Please click here to apply