Local Trial Manager, Single Sponsor Dedicated, Home Based Anywhere In Portugal

Última atualização 2024-06-17
Expira 2024-07-17
ID #2171819211
40,000 €
Local Trial Manager, Single Sponsor Dedicated, Home Based Anywhere In Portugal
Portugal, Lisboa, Lisboa,
Modificado May 28, 2024


Local Trial Manager, Single Sponsor Dedicated, home based anywhere in Portugal page is loaded Local Trial Manager, Single Sponsor Dedicated, home based anywhere in Portugal Apply locations Lisbon, Portugal time type Full time posted on Posted 2 Days Ago job requisition id R1393271 The Role As Local Trial Manager you will be responsible for running international/global studies in all therapeutic areas, managing the operational aspects of projects to meet contractual requirements. You will act as 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. RESPONSIBILITIES OVERVIEWPartner 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)Plan, manage, and maintain oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)Support 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. 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 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: 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)Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of investigator site relationships. REQUIRED EDUCATION AND EXPERIENCEBachelor’s degree in a healthcare or other scientific discipline Minimum 2-3 years’ experience of leading local/regional or global teams Minimum 2-3 years’ clinical trial project management experience Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.). REQUIRED KNOWLEDGELocal knowledge / expertise of regulatory environment, study start up process and associated timelines etc. Clinical trial processes and operations Extensive knowledge of ICH/GCP regulations and guidelines Project and Program management including oversight of study deliverable, budgets and timelines Time, cost and quality metrics, Key performance indicators (KPIs)IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at About Us IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes. To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

Detalhes do trabalho

Tipo de emprego: Tempo total
Tipo de contrato: Permanente
Tipo de salário: Durante o ano
Ocupação: Local trial manager, single sponsor dedicated, home based anywhere in portugal
Min. Salário: 30000

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