Lead Clinical Research Associate (f/m/d)

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 motivated Lead CRA to lead clinical monitoring activities to ensure compliance with study protocols, regulatory requirements and GCP guidelines and the successful conduct/completion of clinical trials.

• Manage assigned clinical studies from site start-up to the close-out visit
• Prepare and coordinate submissions to Competent Authorities and Ethics Committees
• Conduct monitoring visits to ensure patients safety and data integrity
• Build effective relationships with site staff and team members
• Support and management of CROs and freelancer CRAs
• Review and analyze clinical study data for accuracy and completeness
• Ensure availability of essential site documents for filling in the trial master files (TMF)
• Forecast IMP supply and oversight drug accountability
• Provide training to study staff on protocols and related study procedures
• Support in creation, preparation and update of clinical study core documents
• Assist with site selection and contracting procedures
• Oversee and perform operational tasks within the study
• Mentor in-house CRAs new to the position

• At least 2 years of professional experience as an CRA
• Solid knowledge on the conduct of clinical studies, requirements, regulations and ICH/GCP
• Willingness to travel within Europe (max. 30% - irregular, but can be flexibly divided in the team)
• Experience in monitoring global clinical trials is preferred
• Completed scientific studies in relevant life science discipline is an advantage
• Experience with risk-based monitoring, medical device studies desirable
• Talent to mentor and support CRA colleagues
• Ability to strategically plan, prioritize and manage multiple tasks
• Strong attention to detail and accuracy of data
• Strong communication and presentations skills in English
• Experienced Office 365 user

• Open corporate culture with the opportunity to bring in your own ideas
• Great opportunities for personal and professional development
• Attractive work environment with excellent career opportunities and flat hierarchies
• Competitive salary package plus bonus and various benefits
• Gross monthly salary provided for this function is a minimum of EUR 3.800.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.