Clinical Operations Manager

vor 5 Monaten


Wien, Österreich Valneva Vollzeit

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.

**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._



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