Clinical Operations Director
vor 1 Tag
We are a leading vaccine company dedicated to developing and commercializing prophylactic vaccines for infectious diseases. Our team is passionate about making a positive impact on global public health.
As a Clinical Operations Manager at Valneva, you will be responsible for overseeing 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 to ensure adherence to scope of work within timelines and budget
- Interact with other departments and relevant functional areas to ensure seamless collaboration
- May be required to travel to supervise and coordinate clinical studies
- 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
- 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
- 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, 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.
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