Local Trial Manager

ICON plc • Raleigh, NC

2d

About The Position

Local Trial Manager 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: 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 le ad 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

• 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

Nice To Haves

• BA/BS/BSc
• Minimum 3 years’ experience of leading local/regional trial

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 le ad 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.

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, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level