Local Trial Manager - Immunology - Home Based (US)

About the position Local Trial Manager - Immunology - Home Based (US) 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: The L-LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes. The L-LTM will serve as the country-level single point of contact on the study for internal partners. While the L-LTM may delegate tasks to other LTMs or roles on the study, the L-LTM remains accountable for successful completion of those tasks. The L-LTM will manage and oversee the following throughout the study: Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable. Execution of local milestones from feasibility through study close out. Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM). Inspection Readiness and AQR at the country level. Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary. Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence. Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables. Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.

Responsibilities

• Ensuring top-quality end-to-end trial delivery at a country level
• Managing the consistency of Local Trial Management duties and processes
• Serving as the country-level single point of contact on the study for internal partners
• Managing and overseeing Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable
• Execution of local milestones from feasibility through study close out
• Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM)
• Inspection Readiness and AQR at the country level
• Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary
• Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence
• Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables
• Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership

Requirements

• BA/BS degree
• Degree in a health or science related field
• 2 years of local trial management or mutually agreed clinical trial experience
• Start-up & Database Locks/Cleaning experience preferred
• Immunology experience required
• Specific therapeutic area experience may be required depending on the position
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
• Strong IT skills in appropriate software and company systems
• Willingness to travel with occasional overnight stay away from home according to business needs
• Proficient in speaking and writing the country language and English
• Good written and oral communication skills as appropriate
• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Nice-to-haves

• LTM experience in LUPUS/GI preferred

Benefits

• 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, 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.

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