Global Clinical Trial Manager (US/Canada Remote)

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:

• Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
• Supports country-level operational planning and accountable for site selection within assigned country/-ies.
• Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
• Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.
• Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems.
• Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
• Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
• Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
• Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study.
• Responsible for approval of Baseline and Revised Enrolment Plans (Country Level)
• Contributes to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrollment long-range estimates) process.
• Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
• Translates global start up requirements into local country targets
• Monitors country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
• Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
• Monitors and reviews country and study trends.
• Reviews Monitoring Visit Reports.
• Identifies and facilitates resolution of cross-functional study-specific issues.
• Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range).
• Escalates any issues related to delivery, timelines, or budget to GCMs
• Escalates CRA performance issues to applicable Clinical Trial Oversight Manager.
• Conducts onsite quality visits with CRAs where/when appropriate and supports the maintenance of site relationships.

Requirements:

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).
• Previous experience of working with multiple therapeutic areas, including oncology, cardiology/metabolism, infectious disease, immunology and/or vaccines is preferred.
• 6+ years clinical trial management/oversight experience in the pharmaceutical industry or CRO.
• Proven track record in successfully managing various aspects of trials from Start-Up to Database Lock and Trial Closure (End to End study experience).
• Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
• Experience and ability in coordinating global teams in a virtual environment for a minimum of 3 years.
• Willing to travel up to 20%
• To qualify, applicants must be legally authorized to work in the United States and/or Canada, and should not require, now or in the future, sponsorship for employment visa status

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 Program, TELUS Health, 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