ICON Strategic Solutions · 11 hours ago
Local Trial Manager
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 Local Trial Manager to oversee clinical study execution and ensure alignment with global program strategies. The role involves planning, management, and communication with stakeholders to meet study-specific deliverables and operational goals.
Pharmaceuticals
Responsibilities
Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)
Supports country-level operational planning and accountable for site selection within assigned country/-ies
Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents
Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings
Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems
Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies
Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training
Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning
Engages with local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team, DOM)
Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study
Responsible for approval of Baseline and Revised Enrolment Plans (Country Level)
Contributes to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process
Monitors the execution of the clinical study against timelines, deliverables, and budget for that country
Translates global start up requirements into local country targets
Monitors country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions
Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate
Monitors and reviews country and study trends
Reviews Monitoring Visit Reports
Identifies and facilitates resolution of cross-functional study-specific issues
Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range)
Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT lead if appropriate)
Escalates CRA performance issues to applicable Clinical Trial Oversight Manager
Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of site relationships
Qualification
Required
Doctorate degree OR
Master's degree & 3 years of directly related experience OR
Bachelor's degree & 5 years of directly related experience OR
Associate's degree & 10 years of directly related experience
Preferred
BA/BS/BSc
Minimum 3 years' experience of leading local/regional trial
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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