Note: The job is a remote job and is open to candidates in USA. ICON plc is a world-leading healthcare intelligence and clinical research organization. The Clinical Trial Lead will manage the day-to-day operations of assigned trials, ensuring compliance with regulatory requirements and leading cross-functional teams to achieve project goals. Responsibilities • Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements • Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities • Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members • Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data • Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally • Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally • Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team • Lead feasibility assessment and selection of countries and sites for trial conduct • Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables • Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals • Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders • Participates in inspection readiness activities including coordination of clinical study team deliverables • Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable • Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy • Facilitate and manage regional KOL interactions, as applicable • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings • Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct • Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate • Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials Skills • BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements • Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring with a focus on cross-functional team oversight • Requires proven project management skills and trial leadership ability • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability • Phase I oncology experience required • Global experience required (Experience working with China preferred) • Must be open to working PST time as required • Moderate (~25%) travel required Benefits • 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, TELUS Health, offering 24-hour access to a global network of over 80,000 in
