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.
Key Responsibilities:
* Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. (Accountable for study deliverables and drives key decisions within set country)
* 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)
* Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.
* Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.
* Communicate country status (including timelines and deliverables) to key stakeholders (e.g., GCMs, Program Managers, CST or TMT, 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)
* Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
* Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning
* Engage with local cluster team and local functions from a study perspective (e.g., Local Medical, 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
* Accountable for approval of Baseline and Revised Enrolment Plans (Country Level)
* Contribute 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
* Monitor the execution of the clinical study against timelines, deliverables, and budget for that country:
* Translate global start up requirements into local country targets
* Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
* Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate
* Monitor and review country and study trends
* Review Monitoring Visit Reports
* Identify and facilitate resolution of cross-functional study-specific issues
* Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
* Escalate any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate)
* Escalate CRA performance issues to applicable line manager.
* Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
* Execute regulatory agency inspection readiness activities (e.g., TMF review, story board generation)
* Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management
* Participate in cross-functional task forces/process improvement groups
* Assign and oversee deliverables of study support staff e.g., Study Management Associate, CTS , SASM (Snr. Assc. Study management)
* Collaborating with local teams to ensure country level study delivery is aligned with global expectations
* Coordination of the site contracting, budgeting, insurance and payment process by overseeing local support roles (e.g., CTA, SCBA, Legal).
* Identifying risk, implementing risk mitigation strategies, and resolving issues at a country/site level, as well as informing the CST / TMT, LST and local teams of risks associated with delivery in a proactive, timely and solution orientated manner. Contribute to study-levelrisk assessments.
* Leading and continually reviewing country level riskmitigation activities to ensure study delivery to plan
* Maintain relevant therapeutic knowledge
* Triage / tailor communication from study / local team to sites to ensure efficient and effective communicationflow.
Required experience and qualifications
* 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 OR
* High school diploma / GED & 12 years of directly related experience
* Advanced knowledge of global clinical trial management
* BA/BS/BSc
* Minimum 2-3 years’ experience of leading local/regional or global teams
* Minimum 2-3 years’ clinical trial project management experience
* 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, etc.)
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, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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
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