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Global Study Associate- Cell Therapy, Oncology R&d
4 months ago
The Global Study Associate, Cell Therapy is responsible for supporting the delivery of cell therapy 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 nature of the clinical program or study.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. Join us in our **Santa Monica, CA** location. 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.
**Accountabilities**:
- 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.
**Essential Skills/Experience**:
- Bachelor’s degree or equivalent experience
- Minimum of 1-2 years’ experience of administrative/operational support of clinical studies
- United States only: Bachelor’s Degree and 1+ years of experience, Associate’s degree plus 6+ years of experience or High School plus 10+ years of experience
- 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
Why AstraZeneca?
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. A place built on courage, curiosity and collaboration, we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.
Pay Transparency: The annual base salary for this position ranges from $79,822 to $119,734. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity and eligibility to participate in our equity-based long-term incentive program (salaried roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and health benefits, including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as 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.
