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 & BenefitsICON 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.
