ICON Strategic Solutions · 1 week ago
Clinical Trial Manager - Early Oncology
United States
Full-time
Remote
Mid, Senior Level
2+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Clinical Trial Manager to manage the day-to-day operations of assigned trials, ensuring compliance with GCP/ICH guidelines and effective trial execution. The role involves leading cross-functional teams, managing budgets, and ensuring quality across investigative sites.
Responsibilities
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
Qualification
Required
BA/BS degree with at least 3 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial 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
Some travel may be required
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, 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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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