Lead Clinical Research Associate

vor 2 Monaten

Wien, Österreich AOP Orphan Pharmaceuticals GmbH Vollzeit

Fulltime

Vienna

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.

If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative",

***

**Main Benefits**:
**Previous slide**

**Next slide**

**01**

**Bonus**:
Yearly Bonus.

**02**

**Homeoffice**:
Take your focus when needed and stay connected.

**03**

**Mobile Phone**:
Employee mobile phone

**04**

**Flexibility**:
Flexible working hours

**05**

**Laptop**:
Company laptop

**06**

**Education**:
Job training and further education

**07**

**Canteen**:
Canteen on premises

**08**

**Transportation**:
Good connection to public transportation

**09**

**Events**:
Afterwork, Team and All-Company events

**10**

**Doctor**:
Company doctor

**11**

**Parking**:
Parking spot

**Your Contact.**:
**Kathrin Breuer, BA, MA**

**.**

**com**

**Kathrin Breuer, BA, MA**
**HR RECRUITER**

We’re committed to the highest standards of integrity, transparency, and accountability. We value the trust of our business associates, prospective partners, media, and interested parties who are not yet familiar with AOP Health.

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