Clinical Operations Manager (m/f/d)

Jobbeschreibung

Wien, Wien, Österreich
Valneva
14.05.2024
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DescriptionWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.ResponsibilitiesResponsible for all aspects of one or more phase 1-4 clinical studies from protocol through clinical study report finalization for regulatory submissionEnsures compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicableEnsures all operational study deliverables are met according to timelines, budget, operational procedures, and quality standardsManages CROs and other external partners and ensures adherence to scope of work within timelines and budgetInteracts with other departments and relevant functional areasMay be required to travel to supervise and coordinate clinical studiesRequirementsAcademic education, Master or PhD degree in Life ScienceMinimum of 3 years of clinical management experienceProfound knowledge of ICH-GCP, data protection laws, clinical trial directive and other regulations and guidelines relevant for the conduct of clinical trialsIdeally experience in the field of vaccine developmentSupervisory/managerial experience in clinical development including supervision of CROs and/ or CRAs is a mustExcellent communication, presentation, interpersonal, independent problem solving, financial management and leadership skillsOrganized and independent work style with strong systematic approach to prioritization but still detail oriented Excellent command of English (spoken and written) and excellent computer skillsBenefitsOpen, appreciative company culture with innovative spirit and attractive assignmentsInternational surrounding with flat hierarchiesGood team spirit in a strong and highly motivated teamWide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, myClubs, etc.Due to legal reasons we are obliged to disclose the minimum salary for this position, which is 60.000,00 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.Job SummaryID: D83BCB1057Department: 11212Type: full time
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