ICON plc

Local Trial Manager - US Remote

ICON plc

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

JuniorMid-Level

Tech Stack

TypeScript

About the role

  • Planning, management, and oversight of clinical study execution in accordance with the global programs strategy, through leadership of the Local Study Team (LST).
  • Supports country-level operational planning and accountable for site selection within assigned country/ies.
  • Contributes and develops 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 teams and local functions from a study perspective (e.g., Local Medical Affairs team, DOM)
  • Provides country level input to 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 Enrollment Plans (Country Level).
  • Contributes to study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates).
  • Monitors execution of the clinical study against timelines, deliverables, and budget for that country.
  • Translates global startup 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.

Requirements

  • Basic Qualifications: Doctorate degree OR Master's degree & 3 years directly related experience OR Bachelor's degree & 5 years directly related experience OR Associate's degree & 10 years directly related experience
  • Preferred Qualifications: BA/BS/BSc
  • Minimum 2-3 years’ experience of leading local/regional trials