Clinical Trial Manager

Clinical Trial Manager - Phase I OncologyICON 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.What you will be doing:Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirementsLeads or supports cross-functional trial teams, including vendorsEnsures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholdersProactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issuesParticipate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and dataParticipate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial teamParticipate in or lead feasibility assessment and selection of countries and sites for trial conductParticipate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverablesOversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plansParticipate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team membersProvide oversight and direction to trial team members for trial deliverablesManage clinical trial budget and associated vendor contracts, including tracking and data in associated systemsEnsure quality and completeness of TMF for assigned clinical trialsParticipates in inspection readiness activities including coordination of clinical trial team deliverablesParticipate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicableResponsible for the management of budgets, timelines and resources for assigned clinical trial responsibilitiesYour profile:BA/BS degree with at least 3 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial management experienceMust have strong knowledge of ICH/GCP guidelines and regulatory requirementsMust have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoringRequires project management skills and trial leadership abilityMust have excellent interpersonal, written and verbal communication skills, administrative skills and computer abilityFluent in EnglishExperience in Phase I oncologyGlobal experience with primary focus on independent vendor set up and management, oncology cohort management and experience in supporting dose escalation safety meetings.May be asked to Work East coast hours if located further WestModerate (~25%) travel requiredEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.Rewards & BenefitsICON 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 incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Inclusion and AccessibilityICON 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.