Global Study Associate

1 week ago

Gaithersburg, United States AstraZeneca Full time

Description

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 sophisticated 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 supervise 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.

Lead 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 , 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 encourage 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 outstanding and daring 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. Why AstraZeneca? So, what’s next Where can I find out more? Check out our landing page for more information on our BPD group Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Date Posted 26-Jun-2024 Closing Date Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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