Global Study Associate - Gaithersburg, United States - AstraZeneca

AstraZeneca

Verified Company

Gaithersburg, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Global Study Associate

Are you ready to make a significant impact in the field of Oncology? As a Global Study Associate, you will be responsible for supporting the delivery of clinical studies by providing administrative and system support.

This role requires a high degree of flexibility as you will work across several studies. The exact accountabilities will differ depending on the exact nature of the clinical program.

This is your chance to work with diverse minds, all united by a shared passion to learn, grow and discover.

Accountabilities:

In this role, you will be tasked with collecting, reviewing, and tracking relevant study documents. You will support the set-up, maintenance, closeout and archiving of the Trial Master File (TMF). Your responsibilities will also include supporting the production of study documents, ensuring template and version compliance. You will also manage and contribute to the coordination and tracking of study materials and equipment.

Additionally, you will assist in the tracking and reconciliation of invoices and support the study team by providing study metrics/reports during the study, audits, and regulatory inspections.

Essential Skills/Experience:

Bachelor's degree and 1+ years of experience, Associate's degree plus 6+ years of experience or High School Diploma plus 10+ years of experience
Knowledge of ICH-GCP principles
Teamorientated
Ability to coordinate and prioritize multiple tasks and deliverables
Proactive approach
High degree of flexibility
Demonstrated verbal and written communication skills

Desirable Skills/Experience:

Oncology experience
Previous Trial Master File/eTMF experience

When we put unexpected teams in the same room, we unleash 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.

At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe.

As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients.

We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. We are all compassionate team players and driven achievers, always ready to step up. We're motivated by science, success and achieving our goals in a way that's novel and thoughtful.

Are you ready to turn our pipeline into reality to impact unmet patient needs? Our rich and robust pipeline provides the opportunity to work with a variety of ground-breaking medicines across diverse therapy areas and at all stages of the development process.

We work to bring medicines to patients as efficiently and effectively as possible to ultimately address unmet needs across the globe.