Local Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

• Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country level in accordance with ICH-GCP and other applicable local
• Maintains the quality and scientific integrity of clinical trials at a country
• Collaborates with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the
• Maintains expert country, site and protocol knowledge to support sites with questions as well as build strong site
• Partners with global, local country teams and study team to provide high level country strategy, drive study progress and country level study
• Accountable for study deliverables and drives key decisions within set
• 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 – 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
• 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
• 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
• Provides oversight and monitoring of applicable vendor activities 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
• 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)
• Monitors the execution of the clinical study against timelines, deliverables, and budget for that
• Translates global start up requirements into local country targets
• Monitors country enrolment and retention and act on deviations from 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
• Monitors and reviews country and study

What You Need to Have:

• BA/BS/BSc
• Minimum 2-3 years’ experience of leading local/regional or global teams
• Local knowledge / expertise of regulatory environment, study start up process and associated timelines
• Clinical trial processes and operations
• Extensive knowledge of ICH/GCP regulations and guidelines
• Minimum 2-3 years’ clinical trial project management experience
• Minimum 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, )

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.