Clinical Compliance Expert (f/m/d)
part-time (20 hrs/week), as soon as possible
Your Responsibilities
- Regular updates of existing SOPs owned by Clinical Development
- Development of new clinical SOPs
- Training of Clinical Development team on clinical SOPs
- Organization of relevant trainings, including GCP
- Audit Coordinating Person for Clinical Development
- Coordination and support of clinical regulatory inspections in collaboration with QA
- May participation in clinical audits and regulatory inspections
Your Qualifications
- At least 3 years of clinical operations experience or clinical quality assurance
- Profound knowledge of ICH-GCP, data protection laws, clinical study directives and other regulations and guidelines for the conduct of clinical studies
- Experience in holding trainings
- Strong organization and communication skills
- Attention to detail
- Independent working style
- Excellent knowledge in English (written and oral)
- May be required to travel to participate in audits/inspections
Our Offer
- 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 € 42.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.