ICON 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 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 management 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.
May be asked to Work East coast hours if located further West
Moderate (~25%) travel required
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON 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 incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON 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.
Are you a current ICON Employee? Please click here to apply
