Clinical Trial Manager
hace 12 horas
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.
You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks.
You will be partnering with one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.
**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).
- Contributes and develops to program/study-specific materials - e.g., monitoring plan, study specific training documents.
- 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.
- 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).
- 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 and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
- Identifies and facilitates resolution of cross-functional study-specific issues.
- Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate).
- Executes regulatory agency inspection readiness activities (e.g., TMF review, story board generation).
- Collaborates with local teams to ensure country level study delivery is aligned with global expectations.
- Identifies risk, implementing risk mitigation strategies, and resolving issues at a country/si
**What you need**:
- Bachelor’s degree in a health, life sciences, or other relevant field of study.
- Minimum 2-3 years’ work experience in clinical research or experience in Finance/Business
- Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
- Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.
**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
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