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.

  • Clinical Research Associate

    vor 1 Monat

    Wien, Wien, Österreich Pharmig at Vollzeit

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Pharmig at. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by managing site relationships, monitoring study progress, and ensuring compliance with...

  • Clinical Research Associate II

    vor 4 Wochen

    Wien, Wien, Österreich PSI CRO Vollzeit

    Clinical Research Associate Job Description **Job Summary** We are seeking a highly skilled Clinical Research Associate to join our team at PSI CRO. As a Clinical Research Associate, you will be responsible for conducting and reporting onsite and remote monitoring visits, performing CRF review, source document verification, and query resolution. You will...

  • Senior Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich Icon plc Vollzeit

    Overview As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. **Responsibilities**: The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical...

  • Clinical Research Associate II

    vor 3 Wochen

    Wien, Wien, Österreich PSI CRO Vollzeit

    Clinical Research Associate II Job Description **Job Summary** As a Clinical Research Associate at PSI CRO, you will be responsible for conducting and reporting onsite and remote monitoring visits, performing CRF review, source document verification, and query resolution. You will also be responsible for site communication and management, and will be...

  • Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Senior Clinical Research Associate

    vor 3 Wochen

    Wien, Wien, Österreich IQVIA Vollzeit

    Advance Your Career in Clinical Research with IQVIAAs a Senior Clinical Research Associate at IQVIA, you will play a critical role in advancing the field of clinical research. With a strong focus on career growth and professional development, this role offers a unique opportunity to gain direct experience with a leading global contract research...

  • Clinical Research Associate

    Vor 5 Tagen

    Wien, Wien, Österreich Pharmig at Vollzeit

    We are a research-driven biopharmaceutical company dedicated to delivering innovative health solutions and advancing the prevention and treatment of diseases. Our mission is to follow the science and make a significant impact in the world.Role OverviewWe are seeking a Clinical Research Associate to join our team, responsible for ensuring the compliance of...

  • Senior Clinical Research Associate

    vor 1 Monat

    Wien, Wien, Österreich IQVIA Vollzeit

    Advance Your Career in Clinical Research with IQVIAAs a Senior Clinical Research Associate at IQVIA, you will play a critical role in advancing the field of clinical research. With a strong focus on career growth and professional development, this role offers the perfect opportunity to deepen your expertise and take your career to the next level.Your...

  • Senior Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich Proclinical Vollzeit

    Proclinical Staffing are partnered with an established CRO currently looking for an individual to join their team. This role is on a permanent basis located in Austria. The opening position is for an Experienced Clinical Research Associate. **Responsibilities**: - Work alongside and mediate with study team members for project implementation assistance when...

  • Clinical Research Associate

    vor 3 Wochen

    Wien, Wien, Österreich Pharmig at Vollzeit

    We are a research-driven biopharmaceutical company dedicated to inventing medicines and vaccine innovations that make a significant impact on global healthcare. Our Clinical Research and Pharmacovigilance team ensures the safety and efficacy of our products through clinical trials and surveillance.As a Clinical Research Associate, you will be responsible for...

  • Clinical Research Associate

    vor 3 Wochen

    Wien, Wien, Österreich Pharmig at Vollzeit

    We are seeking a highly skilled Clinical Research Associate to join our team at Pharmig at. As a Clinical Research Associate, you will be responsible for ensuring the compliance of studies conducted with ICH/GCP and country regulations, company policies and procedures, quality standards as well as adverse event reporting requirements internally and...

  • Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Research Associate

    vor 5 Monaten

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Research Associate I

    vor 1 Monat

    Wien, Wien, Österreich AUS Fortrea Austria GmbH Vollzeit

    ÜberblickAls führendes globales Auftragsforschungsinstitut (CRO) mit einer Leidenschaft für wissenschaftliche Präzision und einer jahrzehntelangen Erfahrung in der klinischen Entwicklung, bietet Fortrea Kunden aus der Pharma-, Biotechnologie- und Medizintechnikbranche ein breites Spektrum an Lösungen für die klinische Entwicklung, den Patientenzugang...

  • Clinical Research Manager

    vor 5 Monaten

    Wien, Österreich Johnson & Johnson Vollzeit

    (Senior) Clinical Research Manager (m/w/x) Location: Vienna, Austria We are looking for a driven (Senior) Clinical Research Manager to join our growing Clinical Operations team in Austria and Switzerland. The alpine countries are embedded and organized in a D-A-CH concept with Germany completing the cluster of countries. We are conducting the rich portfolio...

  • Clinical Project Manager

    Vor 2 Tagen

    Wien, Wien, Österreich PSI Vollzeit

    Job DescriptionTake your career to the next level and lead challenging full-service global clinical research projects. As a Clinical Project Manager, you will manage the full scope of responsibilities and get hands-on involvement in every aspect of the study.Remote or hybrid options available.Your Responsibilities:Manage global, multi-center clinical...