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E-680 - Manager, Site Operations

Detalles de la oferta

.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.Position: Clinical Site Operations Manager As a Clinical Site Operations Manager, on a Regional level, you will be responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones.Main Responsibilities: Create and maintain clinical trial documents.Participate in the identification, evaluation, and selection of clinical trial sites.Conduct data review.Responsible for tracking of ancillary and investigational supplies, specimens and/or imaging.Support CTMS and Trial Master File completeness.Support audit and/or inspection activities.May manage CRO activities.Support Clinical Trial Manager(s).Collaborate with internal team members, Contract Research Organizations, vendors and sites.Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.May contribute to process improvement initiatives and departmental projects.May act as mentor for less senior staff on the study.Minimum Requirements: BA/BS or equivalent or any relevant and qualifying training with a minimum of 5 years of relevant clinical trial management experience.Oncology clinical research experience.Regional Clinical Trial Management experience.Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative.Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously.Strong communication and inter-personal skills.Highly responsive and proactive, a team player.Knowledge of CFR and GCP/ICH requirements.Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.G., CTMS, EDC and eTMF).Ability and willingness to travel.Fluency in English.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


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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