Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve, no matter where you start with us.
As a global science-led biopharmaceutical company, everything we do comes back to improving the health of our patients worldwide. We seek out new opportunities to do dynamic and significant work, and we encourage our people to continually foster new insights to find different ways of building groundbreaking medicines. This is why, today, we have an unparalleled product portfolio in Oncology, Respiratory and Cardio-Renal Metabolic diseases.
As Local Study Associate Director, you will lead Local Study Teams (LSTs) at the country level to deliver clinical studies according to agreed resources, budget, and timelines complying with AstraZeneca procedural documents, international guidelines as well as relevant local regulations. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.
ACCOUNTABILITIES
The Local Study Associate Director ensures the identification, qualification, setup, initiation, monitoring, and closure of sites for global clinical studies, and proper documentation archiving. They lead Local Study Teams (LSTs) and perform accompanied and required monitoring visits. Key responsibilities include:
- Ensuring study commitments and timely data delivery within the country.
- Leading and optimizing LST performance, ensuring compliance with AstraZeneca’s procedures, ICH-GCP, and local regulations.
- Developing Local Monitoring Plans and performing co-monitoring and QC visits.
- Reviewing monitoring visit reports and advising monitors on study matters.
- Identifying and resolving complex study problems.
- Organizing regular LST meetings and reporting study progress to the Study Leader/Team.
- Contributing to patient recruitment strategies and coordinating with investigators.
- Selecting potential investigators and planning national investigator meetings.
- Assisting in forecasting study needs, coordinating with the Study Drug Coordinator, and ensuring document completeness.
- Facilitating document translations, ensuring timely submissions to Ethics Committees and Regulatory Authorities.
- Setting up and maintaining the study in Clinical Trial Management Systems and ensuring accurate study payments.
- Training new LST members, preparing documents for archiving, and leading audit and inspection activities.
- Providing input for process improvement and regular updates to senior management on study performance and milestones.
- Managing activities and relationships according to company values, guidelines, and Italian legislation.
ESSENTIAL SKILLS/EXPERIENCE
- University degree or equivalent, preferred in biological science or healthcare-related field.
- Minimum 2 years-experience in Clinical Operations.
- A previous experience as CRA.
- Fluent knowledge of spoken and written English and Italian.
- Excellent knowledge of international guidelines - ICH-GCP.
- Good knowledge of relevant local regulations.
- Excellent knowledge in Clinical Operations and understanding of the Clinical Study Process.
- Excellent knowledge/experience of the Monitoring Process.
- Good understanding of the Study Drug Handling Process and Data Management Process.
- Leadership capabilities.
- Excellent project management and organisational skills.
- Goal-oriented.
- Ability to manage several complex projects at the same time.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying, and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. Our combination of curiosity and courage drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.
Apply now to join AstraZeneca’s journey in pushing the boundaries of science
Linked-in
Google