Manager, Clinical Trial Management

What You Will Do You will manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes. Key Responsibilities Lead RBM strategy meetings and develop study-specific site monitoring plans aligned with risk assessment, including SDV and SDR strategies and site monitoring mitigations. Ensure monitoring strategies are configured in technology capabilities (e.g., TSDV). Manage site monitoring assignments in client systems such as CDMS and CTMS. Provide site monitoring training on RBQM and client systems, and support the creation and delivery of initial and ongoing site monitoring materials. Serve as primary reviewer of site monitoring visit reports, ensuring they meet client expectations; escalate concerns to the Clinical Study Manager. Review systems and dashboards to assess site monitoring compliance, triage requests from functional teams, and manage action items in the client CTMS. Support site monitoring needs during study conduct, including triggering monitoring visits and assessing co‑monitoring or multi‑day visit requests; provide backup for monitors during visits. Trigger and manage or conduct Monitoring Oversight Visits to assess site monitoring quality and resolve data or monitoring issues. Partner with the RBQM Operations team to address unresolved centralized monitoring findings with sites and support sites in RBQM processes. Perform periodic assessment of site monitoring/RBM compliance KPIs and KQIs, providing summaries to Study Management and other stakeholders. Maintain accurate documentation of site monitoring activities and serve as the study-level CRO counterpart for site monitoring. Your Profile You will have solid clinical trial management experience, the ability to manage competing priorities, and a capability to develop your team. Required Qualifications And Experience University degree in medicine, science, or an equivalent combination of education and 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 or related roles such as Site Monitoring Management, Risk-Based Monitoring, or Monitoring Excellence. Robust understanding of drug development and clinical trial execution processes. Knowledge of regulatory standards including 21 CFR Part 11 and 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. 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. Global Employee Assistance Programme (LifeWorks) offering 24‑hour access to a global network of professionals who support 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. #J-18808-Ljbffr ICON Strategic Solutions