Oncology Clinical Study Administrator

Are you ready to make a difference in the world of clinical research? At AstraZeneca, we believe in the potential of our people and provide an environment where you can grow beyond your expectations.

As a Clinical Study Administrator (CSA), you'll be at the heart of our mission to deliver life-changing medicines.

Based at our MIND site in Milan, you'll work in a collaborative environment that encourages bold thinking and innovation. Your role will involve coordinating and administering study activities from start-up to close-out, ensuring quality and consistency in study deliverables. 

Accountabilities 

- Assist in coordination and administration of clinical studies from start-up to execution and close-out. 

- Collect, prepare, review, and track documents for the application process. 

- Interface with Investigators, external service providers, and CRAs during document collection. 

- Serve as local administrative main contact and work closely with CRAs and/or LSAD. 

- Maintain local eTMF and ISF, ensuring document tracking compliance. 

- Ensure essential documents are uploaded timely for eTMF "Inspection Readiness." 

- Support CRA in close-out activities for ISF. 

- Contribute to production and maintenance of study documents. 

- Create/import clinical-regulatory documents into Global Electronic Management System. 

- Handle clinical-regulatory documents for electronic applications/submissions. 

- Maintain information in AstraZeneca tracking and communication tools. 

- Prepare/support contract preparation at site level. 

- Prepare/support/perform HCO/HCP payments according to local regulations. 

- Manage coordination and tracking of study materials and equipment. 

- Coordinate administrative tasks during study process, audits, and inspections. 

- Lead practical arrangements for internal and external meetings. 

- Prepare and distribute presentation material for meetings, newsletters, and websites. 

- Responsible for layout, language control, copying, and distribution of documents. 

- Interface with Data Management Centre to facilitate delivery of study-related documents/material. 

- Ensure compliance with AstraZeneca’s Code of Ethics and company policies. 

- Ensure compliance with local, national, and regional legislation. 

Essential Skills/Experience 

  - Master Degree in Lifesciences that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and/or external customers. 

- A previous experience as a Clinical Study Associate/Clinical Trial Assistant or Study Coordinator. 

- Proven organizational and administrative skills. 

- Good verbal and written communication. 

- Good interpersonal skills and ability to work in an international team environment. 

- Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities. 

- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. 

- Computer proficiency. 

- Good knowledge of spoken and written English and Italian. 

- Domicile: Milan

Desirable Skills/Experience 

  - Further studies in administration and/or in life science field are desirable. 

- Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH-GCP guidelines. 

- Ability to develop advanced computer skills to increase efficiency in daily tasks. 

- Willingness and ability to train others on study administration procedures. 

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. 

At AstraZeneca, we are driven by science and success. Our inclusive environment fosters collaboration across locations, therapy areas, and global teams. We embrace change as an opportunity to learn, grow, and evolve. With a rich pipeline offering exposure to the complete drug delivery process, you'll have the autonomy to be an agent of change. We strive for technology adoption and automation to drive efficiencies, ensuring rapid approvals that transform breakthrough science into tangible value for patients. 

Ready to take the next step? Apply now to join our dynamic team! 

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.