Clinical Operations Manager (f/m/d)
100%, indefinite duration, as soon as possible
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
- 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.
- Academic education, Master or PhD degree (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
- Team oriented
- 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)
- Excellent computer skills
- May be required to travel to supervise and coordinate clinical studies
- 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, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events
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.