Are you ready to make a difference in the world of science? At AstraZeneca, we believe in the potential of our people and support them to achieve beyond their expectations.
As a Study Start-Up Manager, you'll play a pivotal role in managing and conducting start-up activities for clinical trials at the country level. Your work will be crucial in ensuring compliance with AZ procedures, international guidelines, and relevant regulations. Collaborate closely with CRAs and the Local Study Team to achieve study milestones efficiently. If you're inspired by science and eager to explore your capabilities, this is the opportunity for you!
- Contribute to ensuring high-quality clinical and operational feasibility assessments for potential studies.
- Accountable for submitting proper applications/documents to Regulatory Authorities and/or IEC/IRB during the start-up period.
- Actively participate in Local Study Team (LST) meetings.
- Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during the start-up period to ensure timely resolution.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs, and local requirements. Support QC checks performed by LSAD or delegate to ensure correctness of trial essential documents prior to study start.
- Provide regular information to Line Managers at the country level on study milestones/key issues during the start-up period.
- Provide feedback on research-related information including sites/investigators/competing studies useful for the local market.
- Support Site Management & Monitoring in various initiatives (local, regional, or global) as agreed with SMM Line Management.
- Scientific Degree or equivalent degree
- Experience (2 years) as Start-up specialist in a pharma company or CRO
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP and relevant local regulations
- Basic understanding of the drug development process
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management
- Excellent attention to details
- Good written and verbal communication skills
- Good collaboration and interpersonal skills
- Good negotiation and problem-solving skills
- Good ability to learn and adapt to work with IT systems
- Fluent in English and Italian
- Based in Milan
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.
AstraZeneca offers an environment where you can thrive alongside top talent, contributing to life-saving medicines and shaping the future of BioPharmaceuticals. With an expanding pipeline, we provide opportunities to build a diverse career with low barriers between areas, allowing you to switch lanes easily. Our commitment to improving patient outcomes drives us forward, making our work truly meaningful.
Ready to take on this exciting challenge? Apply now and be part of our journey!
