Country Study Operations Manager - Home-Based (US)

Overview

As a Clinical Study Operations Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities • Leads and manages the tactical execution of one or more clinical studies from study startup through database release. • Provides quality oversight to the Contract Research Organisation (CRO) and of the CRO deliverables related to study execution. • Leads and coordinates the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports • Will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans. • Core member of the Study Team and will represent the CRO on matters of study execution. • Works with functional lines and directly with CRO line functions to resolve or triage site level issues. • Will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy. • Responsible for Study Management and oversight of all Study Management functions internally and at the CROs • Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies • Accountable for the development of realistic detailed study startup and monitoring plans • Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans • Leads study risk planning process in context of site and subject • Coordinates study/protocol training & investigator meetings • Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs) • Accountable for the delivery of the study against approved plans • Leads inspection readiness activities related to study management and site readiness • May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate • May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.) • Study Management Oversight • Approves the Study Startup, Study Monitoring & protocol recruitment plans • Approves & oversees drug supply management - manages flow of drug supply to the sites & set up Interactive Voice Randomisation System with Supply Chain Lead • Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc. • May support study level submission readiness

Qualifications

Training and Education: • Relevant operational clinical trial experience • A scientific or technical degree is preferred along with knowledge of clinical trial methodology • BA/BS 5+ years of relevant experience • MBA/MS/ 3+ years of relevant experience • BS/BSc/MS/MSc • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility • English is required. Skills: • Extensive global clinical trial/study management experience • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations • Prior Experience Preferred: • Demonstrated study management / leadership experience • Demonstrated oversight of CROs • Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend 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 maximise savings and plan with confidence for the years ahead • Global 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 family's well-being • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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. Apply Job!