Global Study Associate, Oncology R&D, Early Oncology Clinical

The Global Study Associate is responsible for supporting the delivery of clinical studies by providing administrative and system support. The Global Study Associate will work across several studies so a high degree of flexibility is required. The exact accountabilities will differ depending on the exact nature of the clinical program.

Responsabilities:
Collect review and track relevant study documents.
Support set-up maintenance closeout and archiving of the Trial Master File (TMF). Coordinate regular Quality Checks (QC) and review of the TMF ensuring continual inspection readiness.
Support production of study documents ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system.
Set-up populate and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems.
Manage and contribute to the coordination and tracking of study materials and equipment.
Assist in the tracking and reconciliation of invoices.
Support study team and provide study metrics / reports during the study audits and regulatory inspections.
Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings monitor meetings investigator meetings and advisory boards.
Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents.
Prepare and distribute study-related correspondence. Contribute to and distribute material for meetings newsletters and websites.

Desirable Skills/Experience:
University degree / Batchelors degree or equivalent experience
Good understanding of drug development
Minimum of 1-2 years experience of administrative / operational support of clinical studies.
Knowledge of ICH-GCP principles
Team orientated
Ability to coordinate and prioritise multiple tasks and deliverables
Proactive approach
High degree of flexibility
Demonstrated verbal and written communication skills.

hen we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 our commitment to deliver accelerated growth and make peoples lives better. Our Operations team thrives on personal dedication and out-of-the-box thinking. With a focus on Lean processes cutting-edge science digitalization and sustainable practices we are evolving how we work. We offer an inclusive environment where anyone can step up and lead. With global opportunities for career growth and development AstraZeneca is a place where your passion can make a meaningful impact on society.

Ready to take the next step Apply now to join our team and be part of something extraordinary!

Date Posted

Closing Date

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.