Clinical Site Management Lead (30h/week up to full-time)

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a:

We are looking for an experienced and proactive Clinical Site Management Lead to oversee the operational management of clinical studies and ensure high standards of quality, compliance, and collaboration with study sites and partners. 

• Manage assigned clinical studies from site start-up through close-out 
• Prepare and coordinate submissions to Competent Authorities and Ethics Committees
• Conduct co-monitoring visits to ensure patient safety, data integrity, and regulatory compliance 
• Build strong relationships with CRO personnel, site staff, and internal study teams 
• Support and oversee CROs and freelance CRAs 
• Review and analyse clinical study data for accuracy and completeness 
• Ensure availability and quality of essential site documents for the Trial Master File 
• Forecast IMP supply and oversee drug accountability 
• Provide training to CROs and study staff on study protocols and procedures 
• Support the creation, preparation, and maintenance of clinical study core documents 
• Assist with site selection and contracting procedures 
• Oversee and perform operational study activities to ensure smooth trial execution 

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Medical Sciences, or a related field 
• Minimum 5 years of experience as a Clinical Research Associate (CRA) or 2 years as a Senior CRA 
• Strong knowledge of clinical trial conduct, regulatory requirements, and ICH-GCP  
• Experience with submissions to Competent Authorities and Ethics Committees 
• Experience with risk-based monitoring
• Willingness to travel (max. 30% - irregular, but can be flexibly divided in the team) 
• Fluent in English (written and spoken) with strong communication and presentation skills 
• Ability to plan strategically, prioritize tasks, and manage multiple projects 
• Proficient in Office 365 and standard clinical systems 

•  An open corporate culture with the opportunity to contribute your own ideas

• Working independently in a collegial and committed team
• Modern working environment with good public transport connections (U4 - Heiligenstadt)
• Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
• Structured onboarding and support through a buddy system
• Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR EUR 45.080 gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.