ONCOLOGY STUDY START-UP MANAGER

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.
Welcome to MIND (Milan), one of over 400 sites here at AstraZeneca.
The site provides a collaborative environment where everyone feels comfortable and able to be themselves, which is at the core of AstraZeneca’s priorities.
The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities within Site Management and Monitoring unit related to AZ sponsored clinical trials in compliance with the AZ procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.
The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
MAIN DUTIES AND RESPONSIBILITIES Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period Actively participates 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 start-up period to ensure resolution in a timely manner.
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 that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
Support Site Management & Monitoring in different initiatives (local, regional or global) as agreed with the SMM Line Management ESSENTIAL REQUIREMENTS 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 to adapt to work with IT systems Fluent in English and Italian Next Steps – Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Line Manager can know that you feel well qualified for this opportunity.
If you know someone who would be a great fit, please share this posting with them.
Date Posted 05-dic- Closing Date 13-dic- AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Somos una compañía biofarmacéutica global e innovadora.
En AstraZeneca nos enfocamos en el potencial de la ciencia para hacer frente a las necesidades no cubiertas de los pacientes en todo el mundo.
Nos comprometemos en aquellas áreas en las que creemos que realmente podemos cambiar el curso de la medicina y hacer realidad nuevas grandes ideas.
Somos un lugar donde la libertad de pensamiento y la creatividad alimentan nuestra determinación por marcar la diferencia a través de la ciencia.
Nuestra ciencia vive más allá de nuestros laboratorios.
Nuestra perspectiva global significa que utilizamos el talento y la experiencia de todo el mundo para hacer que nuestros medicamentos sean exitosos.
En AstraZeneca el único que puede poner límites al alcance de su carrera eres tú.
Con los conocimientos adecuados y la pasión te ayudaremos a explorar lo que AstraZeneca puede ofrecerte.
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We’re driven to make the right choices and be accountable for our actions.
As an organisation centred around what makes us human, we put a big focus on people.
Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab.
Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you.
to help you realise the full breadth of your potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
And, together with your team, you’ll shape a culture that unites and inspires us every day.
This is your life at AstraZeneca.