Clinical Operations Director

Vor 2 Tagen

Wien, Wien, Österreich Valneva Vollzeit

{"h1": "Clinical Operations Manager at Valneva", "p": "We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our diverse and inclusive workforce makes Valneva a great place to work.

As a Clinical Operations Manager at Valneva, you will be responsible for all aspects of one or more phase 1-4 clinical studies from protocol review through interim analysis until clinical study report finalization for regulatory submission.

Key Responsibilities:

* Ensure compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicable
* Manage CROs and other external partners and ensure adherence to scope of work within timelines and budget
* Interact 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 including at least 2 years with global/regional overall study responsibilities (Global/Regional Study Manager or similar)
* 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 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, full access to LinkedIn Learning,...

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.

If you are a motivated and experienced professional looking for a new challenge, please submit your application.

We look forward to hearing from you

Best regards,

[Your Name]"}

  • Clinical Operations Director

    Vor 2 Tagen

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    About UsWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.Our MissionWe have leveraged our expertise and capabilities to commercialize three vaccines, including the world's first and only chikungunya vaccine.Job SummaryWe are seeking a highly skilled...

  • Clinical Operations Director

    vor 2 Wochen

    Wien, Wien, Österreich Valneva Vollzeit

    About ValnevaWe are a leading biotechnology company that specializes in the development, manufacturing, and commercialization of prophylactic vaccines for infectious diseases addressing unmet medical needs.Our company has leveraged its expertise and capabilities to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to...

  • Clinical Operations Director

    vor 2 Wochen

    Wien, Wien, Österreich Valneva Vollzeit

    We are a leading vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine...

  • Clinical Operations Manager

    vor 1 Woche

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    {"Job Title": "Clinical Operations Manager", "Job Description": "Job SummaryWe are seeking a highly skilled Clinical Operations Manager to join our team at Valneva Austria GmbH. As a key member of our clinical development team, you will be responsible for ensuring the successful execution of clinical studies from protocol through clinical study report...

  • Clinical Operations Manager

    Vor 2 Tagen

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    Job Title: Clinical Operations ManagerWe are a leading vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our team is committed to making a positive impact on global public health.Key Responsibilities:Manage all aspects of one or more phase 1-4 clinical studies from...

  • Clinical Laboratory Operations Supervisor

    vor 4 Wochen

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    Company OverviewValneva Austria GmbH is a pioneering vaccine organization dedicated to the development, production, and commercialization of preventive vaccines targeting infectious diseases that fulfill unmet medical needs. With a robust portfolio that includes the world's first chikungunya vaccine, we are advancing a diverse array of vaccine candidates...

  • Experienced Clinical Research Associate

    vor 2 Wochen

    Wien, Wien, Österreich Medpace Vollzeit

    Job SummaryMedpace is seeking an Experienced Clinical Research Associate to join our Clinical Operations team in a home-based setting. This role will work on a team to accomplish tasks and projects that are instrumental to the company's success.Key ResponsibilitiesConduct qualification, initiation, monitoring, and closeout visits for research sites in...

  • Research Associate

    vor 2 Wochen

    Wien, Wien, Österreich IQVIA Vollzeit

    Job Summary:IQVIA is seeking a highly skilled Senior Clinical Research Associate to join our team in a home-based setting throughout Austria. As a Senior Clinical Research Associate, you will be responsible for performing site selection, initiation, monitoring, and close-out visits, as well as supporting the development of a subject recruitment plan.Key...

  • Director of European Transport Operations

    vor 2 Wochen

    Wien, Wien, Österreich Mondelēz International Vollzeit

    Job SummaryThe Director of European Transport Operations will be responsible for managing the European transport control tower, overseeing transport, customs, and pallets management operations across Europe. This role requires strategic thinking, leadership, and problem-solving skills to drive continuous improvement and deliver year-on-year productivity.Key...

  • Clinical Research Associate

    Vor 4 Tagen

    Wien, Wien, Österreich Medpace Vollzeit

    Job SummaryMedpace is seeking an Experienced Clinical Research Associate to join our Clinical Operations team in Austria (home-based). This role will work on a team to accomplish tasks and projects that are instrumental to the company's success.Key ResponsibilitiesConduct qualification, initiation, monitoring, and closeout visits for research sites in...

  • Laboratory Operations Supervisor

    vor 4 Wochen

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    Company OverviewValneva Austria GmbH is a leading specialty vaccine organization dedicated to the development, manufacturing, and commercialization of prophylactic vaccines targeting infectious diseases with significant unmet medical needs. Our commitment to public health is reflected in our successful commercialization of three vaccines, including the...

  • Laboratory Operations Supervisor

    vor 4 Wochen

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    Company OverviewValneva Austria GmbH is a pioneering vaccine organization dedicated to the development, production, and marketing of preventive vaccines targeting infectious diseases with significant unmet medical needs. Our expertise has led to the successful commercialization of three vaccines, including the world's first chikungunya vaccine, while also...

  • Laboratory Operations Manager

    vor 4 Wochen

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    Company OverviewValneva Austria GmbH is a pioneering vaccine enterprise dedicated to the development, production, and marketing of preventive vaccines targeting infectious diseases that fulfill unmet medical requirements. Our extensive expertise has enabled us to successfully commercialize three vaccines, including the world’s first chikungunya vaccine,...

  • Laboratory Operations Manager

    vor 4 Wochen

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    Company OverviewValneva Austria GmbH is a pioneering vaccine organization dedicated to the development, production, and marketing of preventive vaccines for infectious diseases that meet critical medical needs. Our extensive expertise has enabled us to successfully commercialize three vaccines, including the world’s first chikungunya vaccine, while...

  • IT Director

    Vor 6 Tagen

    Wien, Wien, Österreich Mandarin Oriental Hotel Group Limited Vollzeit

    Job Title: Director of ITThe Director of IT is a critical role within the Mandarin Oriental Hotel Group Limited, responsible for ensuring the compliance of the Information Technology and Audio Visual environment across the organization. This includes adherence to Payment Card Industry (PCI) regulations, local data regulations, network security compliance,...

  • Central Laboratory Operations Supervisor

    vor 4 Wochen

    Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    Company OverviewValneva Austria GmbH is a pioneering vaccine organization dedicated to the development, production, and commercialization of preventive vaccines targeting infectious diseases with significant unmet medical needs. Our expertise has enabled us to successfully launch three vaccines, including the world's first chikungunya vaccine, while...

  • IT Director

    Vor 6 Tagen

    Wien, Wien, Österreich Mandarin Oriental Hotel Group Limited Vollzeit

    IT Director Job DescriptionThe IT Director at Mandarin Oriental Hotel Group Limited is responsible for ensuring the compliance of the Information Technology and Audio Visual environment within the hotel or hotels they are responsible for. This includes, but is not limited to, Payment Card Industry (PCI) regulations, local data regulations, network security...

  • Clinical Project Manager

    vor 2 Wochen

    Wien, Wien, Österreich PSI Vollzeit

    Job SummaryPSI is seeking a highly experienced Clinical Project Manager to lead global clinical research projects from startup to closure. As a key member of our research and development team, you will be responsible for managing multi-functional project teams, delivering projects on time and within budget, and ensuring high-quality standards are met.Key...

  • Director of IT Manufacturing Operations

    Vor 4 Tagen

    Wien, Wien, Österreich Takeda Pharmaceutical Vollzeit

    About the RoleWe are seeking an experienced Associate Director to lead our IT Manufacturing Operations team. As a key member of our organization, you will be responsible for overseeing and managing all services that enable applications and operations at the shopfloor level of manufacturing production lines.Key ResponsibilitiesGuide and support a team...

  • Clinical Site Technology Specialist

    Vor 3 Tagen

    Wien, Wien, Österreich PSI CRO Vollzeit

    Clinical Site Technology SpecialistWe are seeking a highly skilled Clinical Site Technology Specialist to join our team at PSI CRO. As a key member of our team, you will be responsible for providing technical support and expertise to clinical sites related to technology, including kidney imaging, cell therapy, radiology, and renal ultrasounds.Key...