Senior Clinical Trial Manager

About the role

The Senior Local Trial Manager - Immunology will manage and oversee various aspects of studies, including central IRB and local vendors, execution of local milestones, resourcing of country-level roles, inspection readiness, and AQR.

Responsibilities

• Manage and oversee central IRB and local vendors (e.g. Greenphire, Drug Destruction services).
• Set up vendor purchase orders, invoice review and approval, and handle change-orders.
• Execute local milestones from feasibility through study close out.
• Resourcing of country-level roles, including support with transitions, in collaboration with the study Functional Manager.
• Inspection readiness and AQR at the country level.
• Collaborate with assigned Local Trial Managers, Lead Site Managers, Site Managers, CTAs, and SCMs to outline accountabilities and responsibilities.
• Communicate with Clinical Trial Managers, Clinical Operations, and the Global Trial Leader to ensure trial excellence.
• Participate in country-level ad hoc meetings to address unexpected circumstances impacting country or study level deliverables.
• Provide updates, discuss hurdles, timelines/resources, and assist with documentation to leadership.

Requirements

• Bachelor's degree in a health or science-related field.
• 3-5+ years of trial end-to-end management experience.
• Start-up and database locks/cleaning experience preferred.
• Immunology trial management experience highly preferred.
• Strong working knowledge of ICH-GCP, company SOPs, local laws and regulations, assigned protocols, and associated procedures.
• Strong IT skills in relevant software and company systems.
• Willingness to travel with occasional overnight stays.
• Proficiency in the country language and English.
• Good written and oral communication skills.

Qualifications

• Legally authorized to work in the United States.
• Willingness to travel with occasional overnight stays.

Skills

• Strong project management skills.
• Excellent communication and interpersonal skills.
• Knowledge of ICH-GCP and local regulations.
• IT proficiency in relevant software and company systems.

Benefits

ICON offers a comprehensive benefits package including various annual leave entitlements, health insurance options, retirement planning, and a global Employee Assistance Program (EAP). Additional optional benefits may also be available based on location.