Clinical Operations Manager
vor 1 Woche
**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.
**Requirements**:
- 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
**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, 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._
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