An opportunity to join a large global CRO in ICON as a Trial Manager for an exciting sponsor program!! 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 systems Ensure quality and completeness of TMF for assigned clinical trials Participates 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 responsibilitiesYou are:BA/BS degree with at least 3 years clinical trial experience. Advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience Must 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 EnglishModerate (~25%) travel requiredWhat ICON can offer you:Our success depends on the quality of our people. Thats why weve 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 entitlementsA range of health insurance offerings to suit you and your familys needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersAt ICON, inclusion & belonging are fundamental to our culture and values. Were 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.
Job Title
Clinical Trial Manager