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 Lead Clinical Research Associate (f/m/d).
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.
What Your Day To Day Will Look Like
- 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
Your Qualifications and Experience
- 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
Our Offer
- 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.
