Oncology Clinical Study Administrator

AstraZeneca; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A biopharmaceutical company in Milan is seeking a Clinical Study Administrator. You will coordinate clinical studies, ensure compliance with regulations, and support study documentation. Ideal candidates will have a Master's in Life Sciences and experience in clinical roles, coupled with strong organizational skills and bilingual communication abilities.

Competenze

• Master's Degree in Life Sciences supporting skills for the role.
• Previous experience in clinical study roles.
• Good knowledge of spoken and written English and Italian.

Mansioni

• Coordinate and administer clinical studies from startup to closeout.
• Prepare and track documents for application processes.
• Interface with investigators and service providers.

Conoscenze

Organizational skills

Administrative skills

Good communication

Interpersonal skills

Team-oriented

Computer proficiency

Bilingual (English and Italian)

Formazione

Master's Degree in Life Sciences

Descrizione del lavoro

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 startup to closeout, ensuring quality and consistency in study deliverables.

Accountabilities

• Assist in coordination and administration of clinical studies from startup to execution and closeout.
• Collect, prepare, review, and track documents for the application process.
• Interface with Investigators, external service providers, and CRAs during document collection.
• Serve as the local administrative main contact and work closely with CRAs and LSAD.
• Maintain local eTMF and ISF, ensuring document tracking compliance.
• Ensure essential documents are uploaded timely for eTMF Inspection Readiness.
• Support CRA in closeout activities for ISF.
• Create/import clinical/regulatory documents into the 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 materials 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/materials.
• Ensure compliance with AstraZeneca's Code of Ethics and company policies.
• Ensure compliance with local, national, and regional legislation.

Essential Skills / Experience

• Master's Degree in Life Sciences supporting skills and capabilities for the role.
• 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, with attention to detail and ability to multitask.
• Team-oriented and flexible, with quick responsiveness to shifting demands.
• Computer proficiency.
• Good knowledge of spoken and written English and Italian.

Domicile: Milan

Desirable Skills / Experience

• Further studies in administration or life sciences.
• Knowledge of the Clinical Study Process and ICH-GCP guidelines.
• Ability to develop advanced computer skills.
• Willingness to train others on study administration procedures.

We work on average a minimum of three days per week from the office, balancing flexibility with in-person collaboration. Join us to be part of a diverse and innovative team committed to transforming science into tangible value for patients.

Apply now to join our dynamic team!

AstraZeneca is an equal opportunity employer. We consider all qualified applicants without discrimination based on disability, sex, sexual orientation, pregnancy, race, age, religion, gender identity, marital status, veteran status, or any other protected characteristic.

Important Dates

Posted: 09 May 2025

Closing Date: 23 May 2025