ICON Strategic Solutions · 2 hours ago
Senior Local Trial Manager - Oncology - Home Based (US)
United States
Full-time
Remote
Mid, Senior Level
3+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Senior Local Trial Manager to ensure top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes.
Responsibilities
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
Autonomy with execution of local trial management services
Depth of knowledge with local trial management services
Process leadership
Qualification
Required
BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial management experience; pharmaceutical and/or CRO experience
Oncology Solid Tumor experience
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
Preferred
Start-up & Database Locks/Cleaning experience
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
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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