Local Clinical Trial Manager

Local Clinical Trial Manager
Empresa:

Icon Strategic Solutions


Lugar:

Portugal


Detalhes da Vaga

.As a Clinical Team Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: 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. Communicate country status (including timelines and deliverables) to key stakeholders (e.G., GCMs, Program Managers, CST or TMT). 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. Planning, management, and oversight of clinical study execution in accordance with the global program strategy. Maintain expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships. Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level. Maintain the quality and scientific integrity of clinical trials at a country level. Collaborate with cross functional internal and external stakeholders to ensure timely execution and budget execution of clinical trials. 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 regulations. Support country-level operational planning and accountable for site selection within assigned country(ies). Engage with local cluster team and local functions from a study perspective (e.G., Local Medical, DOM). Accountable for approval of Baseline and Revised Enrolment Plans (Country Level). 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. Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate. Review Monitoring Visit Reports. Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation. You are: A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. Minimum four years clinical trial management experience. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. What ICON can offer you: Our success depends on the quality of our people


Fonte: Jobtome_Ppc

Função de trabalho:

Requisitos

Local Clinical Trial Manager
Empresa:

Icon Strategic Solutions


Lugar:

Portugal


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