Manager, Clinical Trial Management

POL-HB-SML

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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) 
• May require up to 50 % travel, potentially including overnight and international travel

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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