Global Study Associate
1 week ago
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Position Summary
The Study Associate, Cell Therapy is responsible for supporting the delivery of cell therapy clinical studies by providing administrative and system support. The Study Associate will work across several studies, so a high degree of flexibility is required. The exact accountabilities will differ depending on the nature of the clinical program or study. You will report to the Director Study Leader, Cell Therapy or equivalent.
Responsibilities
Collect, review, and track relevant study documents. Support setup, maintenance, closeout and archiving of the Trial Master File (TMF), including restricted TMF sections for Cell Therapy-specific documents. 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 materials for meetings, newsletters, and websites.
Education and Experience
Bachelor's degree plus 1+ years, Associate's degree plus 6+ years or High School plus 10+ years of experience Minimum of 1-2 years' experience of administrative/operational support of clinical studies Knowledge of ICH-GCP principles Team oriented Ability to coordinate and prioritize multiple tasks and deliverables Proactive approach to accomplishing study goals High degree of flexibility Demonstrated verbal and written communication skills
When we put unexpected teams in the same room, we fuel 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.
The annual base salary for this position ranges from $79,000 to $119,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an “at-will position” and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Benefits
Short-term incentive bonus opportunity Equity-based long-term incentive program 401(k) plan Paid vacation and holidays; paid leaves Health benefits including medical, prescription drug, dental, and vision coverage.
DE&I Statement
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.
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