Clinical Trial Lead - Early Phase Oncology

Clinical Project Manager

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 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

Your profile:

• 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

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Salary range: $133,736.00-$167,170.00

Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

Are you a current ICON Employee? Please click here to apply