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 to read more about the benefits ICON offers.