Clinical Trial Manager - early oncology

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

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 requirements

• Leads or supports cross-functional trial teams, including vendors

• Ensures 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 stakeholders

• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues

• Participate 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 data

• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team

• Participate in or lead feasibility assessment and selection of countries and sites for trial conduct

• Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables

• Oversee 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 plans

• Participate 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 members

• Provide oversight and direction to trial team members for trial deliverables

• Manage 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 deliverables

• Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable

• Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities

Your 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 experience 

• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements

• Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring

• Requires project management skills and trial leadership ability

• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability

• Fluent in English

• Experience in Phase I oncology

• Global experience with primary focus on independent vendor set up and management, oncology cohort management and experience in supporting dose escalation safety meetings.

• Moderate (~25%) travel required

What ICON can offer you:

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.

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