Reithera Srl


Clinical Operations Manager

We are currently looking for a Clinical Operations Manager that will be responsible for providing support to the regulatory strategy for the assigned projects. He/She will focus on: • Oversee, lead and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials in compliance, on time and on budget • Coordination/execution of all operational aspects of clinical studies (including availability of clinical supplies at the sites, review and approval of request for investigational test articles) • Identify, qualify, audit, and manage all external vendors, including CROs • Assist with the development of presentations, handouts, and coordination of Investigator meetings, prepare meeting minutes • Maintain TMF related to ongoing studies and all regulatory documentation • Update, review, and maintain electronic databases for clinical trials. • Strict cooperation and synergy with scientific team, manufacturing unit, regulatory affairs, and biostatistics, being part of a cross functional team • Regulatory correspondence with PI's and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates • Analyze preclinical/clinical research data, perform literature searches and extract information to support regulatory documents and prepare reports on findings Requirements: • University degree in life scientific (preferably biological science, biotechnology, pharmacy or pharmaceutical chemistry) • At least 3 year of experience in healthcare companies in clinical research and/or clinical project management experience in domestic and international clinical trials • Excellent working knowledge of ICH GCP guidelines, EMA, and HIPAA regulations • Good English written and verbal communication skills with the ability to effectively and precisely present data • Attention to details with proven ability to establish priorities & achieve results • Multitasking attitude and problem-solving approach • High quality and ethical standards

Riferimento annuncio: 3700
Data Pubblicazione: 20 settembre 2018
Luogo di svolgimento: Roma [RM] - Lazio
Settore: Qualità, Sicurezza e Ambiente
Tipo di contratto: Tempo determinato

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