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<ul><li>Leads, motivates, sets objectives, and manages performance of the assigned resources to assure completion of organizational goals, in a diverse and inclusive environment</li> <li>Ensure the execution of the clinical trials entrusted to the Sponsor in compliance with the deadlines, guaranteeing the achievement of the qualitative/quantitative objectives agreed with the Sponsor.</li> <li>Coordinate and drive all the clinical services involved in the project (Medical Writing, Start-up, Data Management, Biostatistics, Feasibility, Monitoring) during the entire life cycle of the study and as per applicable SOPs, budget and timelines agreed internally and with Sponsor and applicable regulations.</li> <li>Act as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timelines).</li> <li>Lead the periodical Sponsor meeting/Call. Finalize and approve the related minutes.</li> <li>Acquire the study documentation produced by the Sponsors and collaborate and coordinate the study core documents preparation required for the submission and application for approval of the study.</li> <li>Preparation and maintenance of Study Manuals.</li> <li>Set-up and maintenance of the Trial Master File.</li> <li>Set-up and maintenance of the Investigator Study File and coordination of delivery to experimental centers involved in the study.</li> <li>Lead the monitoring activities as per monitoring plan, budget and agreement with Sponsor.</li> <li>Keep aligned, with expected metric, the timelines related to the Monitoring visit report delivery.</li> <li>Provide specific study training (Protocol, CRF, etc.) for the 1MED Study team and, where required, for the hospital staff involved.</li> <li>Participation in Investigator Meetings and/or teleconferences related to the assigned study and drafting of the minute.</li> <li>Manage the findings found during an audit/inspection of a clinical trial and ensure that the necessary corrective actions are implemented.</li> <li>Ensure that serious adverse events are managed in accordance with the protocol and applicable legislation.</li> <li>Implement and maintain the necessary procedures for the management of clinical trials in accordance with GCP/ISO/MDD/MDR and all applicable regulation.</li> <li>Report major violations of protocol, GCP and SOPs to the Head of Quality Assurance and Top Management.</li> <li>Escalate to the direct superior all deviation from the qualitative/quantitative objectives, deadlines and budgets</li> </ul><br/><ul><li>Swiss Company|Medical Devices and Pharmaceuticals</li></ul><br/><p>Bachelor / Master of Science / Master's Degree in scientific disciplines or equivalent experience (at least 10 years) in Clinical trial- related activities</p> <br/><p>CRO based in Switzerland</p> <br/><p>Permenent Contract <br /><br />Swiss Contract</p> <br/><p></p>