Global Trial Manager - Early Development

IRE • Cary, NC

2d

About The Position

Global Trial Manager - Early Development 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: Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan Develops the strategic scenarios of designs for early phase clinical development plan Ensures standard processes, tools, and procedures are used consistently Routine engagement with Clinical Investigators Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations Ongoing safety data review and completion of study data collection, data lock, and analysis Resolution of cross-functional study-specific issues Communication of study status to key stakeholder and updating relevant systems Ensures study personnel are appropriately trained and understand study timelines and deliverables Manages study budget & communication of budget changes Drives the writing and/or review of study design, synopsis, protocols, supplements, amendments and Investigational Product Instructional Manuals (IPIM) Contributes operational input to: Study related documentation, including safety and regulatory documents, Clinical Study Reports, Case Report Forms, and other study-related documents Identifies site selection and feasibility in partnership with the Dev. Feasibility Manager Assists in selection, set up, and management of vendors, including invoice approval Organizes and leads investigator meetings where appropriate

Requirements

• BA/BS/BSc or RN
• At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
• Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
• Strong clinical project management skills and experience in driving milestones.
• Excellent communication and interpersonal skills to effectively work with cross-functional teams.
• Proficient in trial management systems and MS Project (or equivalent PM software).
• Knowledge of ICH/GCP and regulatory guidelines/directives

Responsibilities

• Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
• Develops the strategic scenarios of designs for early phase clinical development plan
• Ensures standard processes, tools, and procedures are used consistently
• Routine engagement with Clinical Investigators
• Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
• Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
• Ongoing safety data review and completion of study data collection, data lock, and analysis
• Resolution of cross-functional study-specific issues
• Communication of study status to key stakeholder and updating relevant systems
• Ensures study personnel are appropriately trained and understand study timelines and deliverables
• Manages study budget & communication of budget changes
• Drives the writing and/or review of study design, synopsis, protocols, supplements, amendments and Investigational Product Instructional Manuals (IPIM)
• Contributes operational input to: Study related documentation, including safety and regulatory documents, Clinical Study Reports, Case Report Forms, and other study-related documents
• Identifies site selection and feasibility in partnership with the Dev. Feasibility Manager
• Assists in selection, set up, and management of vendors, including invoice approval
• Organizes and leads investigator meetings where appropriate

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees