Clinical Operations Manager

vor 4 Wochen

Vienna, Österreich Valneva Vollzeit

We 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.

Responsibilities
  • Responsible for all aspects of one or more phase 1-4 clinical studies from protocol through clinical study report finalization for regulatory submission
  • Ensures compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicable
  • Ensures all operational study deliverables are met according to timelines, budget, operational procedures, and quality standards
  • Manages CROs and other external partners and ensures adherence to scope of work within timelines and budget
  • Interacts with other departments and relevant functional areas
  • May be required to travel to supervise and coordinate clinical studies

Requirements

  • Academic education, Master or PhD degree in Life Science
  • Minimum of 3 years of clinical management experience
  • Profound knowledge of ICH-GCP, data protection laws, clinical trial directive and other regulations and guidelines relevant for the conduct of clinical trials
  • Ideally experience in the field of vaccine development
  • Supervisory/managerial experience in clinical development including supervision of CROs and/ or CRAs is a must
  • Excellent communication, presentation, interpersonal, independent problem solving, financial management and leadership skills
  • Organized and independent work style with strong systematic approach to prioritization but still detail oriented
  • Excellent command of English (spoken and written) and excellent computer skills

Benefits

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide 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.

  • Clinical Operations Manager

    vor 1 Monat

    Vienna, Österreich Valneva Vollzeit

    We 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...

  • Clinical Operations Manager

    vor 2 Wochen

    Vienna, Österreich IQVIA Vollzeit

    Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential Functions Oversee the execution of Site Activation (including pre-award/bid defense...

  • Senior Financial Manager

    vor 2 Wochen

    Vienna, Österreich Tether Operations Limited Vollzeit

    Together with its partner companies, Tether Edu aims at offering tailored workshop and masterclass’ programmes providing a smart educational environment that promotes self development, skill-set stimulation and self realisation. The tutorship platform in whole, is based on the identification and implementation of latest trends and expertise in specific...

  • Legal Operations Manager

    vor 4 Wochen

    Vienna, Österreich Alliance Defending Freedom Vollzeit

    Everyone says they want to change the world. We're looking for people who actually will. ADF International is a faith-based legal advocacy organization that protects fundamental freedoms and promotes the inherent dignity of all people. Please visit our career site to view our Statement of Faith and Doctrinal Distinctives.Legal Operations ManagerADF...

  • Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA

    vor 2 Wochen

    Vienna, Österreich IQVIA Vollzeit

    Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

  • Associate Manager, Clinical Trials Regulatory Management

    vor 2 Wochen

    Vienna, Österreich IQVIA Vollzeit

    Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...

  • Clinical Research Associate

    vor 1 Monat

    Vienna, Österreich Pharmig at Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Clinical Trials Vendor Management Specialist

    Vor 5 Tagen

    Vienna, Österreich PSI CRO Vollzeit

    Job DescriptionYou will be responsible for supporting the establishment of approaches, processes and information flow, along with building strong relationships to ensure effective collaboration between PSI teams and PSI vendors. You willReview external vendor quotationsMaintain vendor databases and tracking systemsSupport vendor identification, assessment...

  • Clinical Trials Vendor Management Specialist.

    Vor 5 Tagen

    Vienna, Österreich PSI Vollzeit

    Job Description You will be responsible for supporting the establishment of approaches, processes and information flow, along with building strong relationships to ensure effective collaboration between PSI teams and PSI vendors.  You will Review external vendor quotations Maintain vendor databases and tracking systems Support vendor...

  • Senior Field Clinical Specialist

    vor 4 Wochen

    Vienna, Österreich Abbott Vollzeit

    About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in...

  • City Operations Manager

    vor 1 Monat

    Vienna, Österreich Just Eat Takeaway.com Vollzeit

    Hungrig nach einer Herausforderung?Unsere Geschichte Viele dieser Aufträge erfolgen dank „Scoober“, der Logistikabteilung unseres Geschäfts. Unsere treuen Scoober-Fahrer/innen liefern immer… egal bei welchem Wetter! Und hier kommst Du ins Spiel...Dein JobAls Standortleiter/in (City Operations Manager) übernimmst Du die Verantwortung für unser Hub...

  • Ad Operations Manager

    vor 4 Wochen

    Vienna, Österreich bwise Media AG Vollzeit

    About bwise Mediabwise is an international digital media agency, specialized in the monetization of sports websites and apps and furthermore specialized in managing advertising sales to sports betting operators. Our partners are the biggest and most popular sports portals around the world. If you are enthusiastic about digital marketing, especially around...

  • Regulatory and Start Up Line Manager

    vor 4 Wochen

    Vienna, Österreich IQVIA Vollzeit

    Job Overview Manages a single department or work unit responsible for site activation. Sets goals and objectives for team members for achievement of short-term operational or tactical results. Must have former people management experience. Essential Functions Manages staff's delivery of site activation activities in accordance with...

  • Logistik Operations Führungskraftnachwuchs

    vor 1 Monat

    Vienna, Österreich Österreichische Post AG Vollzeit

    Berufsfeld: Logistik/Sortierung Das sind wir und das bewegt uns Wir sind ein modernes Logistikunternehmen mit hochtechnisierter Infrastruktur und vielen digitalen Angeboten und Services. Wir befördern Briefe, Werbesendungen und Pakete, bieten analoge und digitale Werbung, E-Commerce, Geschäftsprozesslösungen und an unseren Post-Standorten auch...

  • Operations Manager

    vor 2 Wochen

    Vienna, Österreich Intermarket Bank AG Vollzeit

    Operations Manager - Factoring (w/m/d) Die Intermarket Bank AG der Erste Group ist die Spezialbank für Factoring und Supply Chain Finance der Erste Bank und Sparkassen. Sie betreut rund 400 Kunden der mittelständischen Wirtschaft und Großkunden. Das Team Operations stellt die Grundlage für die operativen Abläufe in Sachen Betreuung von unseren...

  • Local Trial Manager

    vor 1 Woche

    Vienna, Österreich IQVIA Vollzeit

    The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas. We currently offer the...

  • Operation & Maintenance Manager (m/w/d) für Wasserkraftwerke

    vor 4 Wochen

    Vienna, Österreich ANDRITZ Vollzeit

    Tagtäglich liefert ANDRITZ erfolgreiche und innovative Lösungen an Kunden auf der ganzen Welt. Warum sind wir so erfolgreich? Weil wir mit Begeisterung bei der Sache sind und lieben, was wir tun! Mit unseren wegweisenden Lösungen im Bereich zukünftiger Engineering-Technologien stehen wir ganz vorne, um den Erfolg unserer Kunden in Schlüsselindustrien...

  • Operation Manager im Catering

    vor 4 Wochen

    Vienna, Österreich FromFranz Catering Vollzeit

    Du bist engagiert, motiviert und hast Erfahrung im Cateringbereich?Du möchtest Teil eines jungen, dynamischen und positiven Teams sein?Selbstständiges Arbeiten fällt dir leicht?Du liebst den direkten KundInnenkontakt?Personalführung während eines Events ist genau dein Ding? Dann würden wir uns freuen, von dir zu hören! Aufgaben Das FromFranz Catering...

  • Technical Operations Liaison Engineer

    vor 4 Wochen

    Vienna, Österreich Ryanair Vollzeit

    Ryanair Holdings plc is the parent company of Ryanair DAC, Lauda Europe, Buzz, Malta Air and Ryanair UK.DM Aircraft Maintenance are the dedicated engineering maintenance provider based in Vienna, Austria providing comprehensive maintenance on the Lauda Europe A320 and Ryanair B737 fleet of aircraft.We are currently recruiting a Technical Operations Liaison...

  • Technical Operations Liaison Engineer

    vor 4 Wochen

    Vienna, Österreich Ryanair Vollzeit

    Ryanair Holdings plc is the parent company of Ryanair DAC, Lauda Europe, Buzz, Malta Air and Ryanair UK. DM Aircraft Maintenance are the dedicated engineering maintenance provider based in Vienna, Austria providing comprehensive maintenance on the Lauda Europe A320 and Ryanair B737 fleet of aircraft. We are currently recruiting a Technical Operations...