Global Study Associate - Early Oncology Clinical Operations

Job description

*Global Study Associate - Early Oncology Clinical Operations*
*Permanent opportunity *
*UK - Cambridge *

Do you have expertise in, and a passion for, Early Oncology Clinical Operations? Would you like to apply your expertise to impact the lives of patients living with cancer, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

*About AstraZeneca*AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

*Site description*Welcome to Cambridge, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities, it's important to us that you bring your full self to work every day. To help you maintain your best self, here's a sneak peek into some of the things this site provides for you…

Where Science thrives…Cambridge is one of the most exciting bioscience hotspots in the world, playing a central role in our mission to deliver life changing medicines to patients across the globe.

This role could be located in either the Melbourn Science Park or the Central Cambridge offices.

Located in stunning offices set in 17 acres of landscaped grounds. The Melbourn Science Park offers an impressive mix of refurbished open plan office space on two floors and a suite of fully furnished conference and meeting rooms. The building benefits from a full height atrium and stunning views overlooking the lake.

Central Cambridge - Located in walking distance from the Train station, you will have access to an onsite gym, restaurant facilities and experience working within a calm and relaxing agile environment, inspired by the University Botanical gardens.

Both sites provide access to a stylish, fully air conditioned fitness centre, an onsite restaurant, Lunch & Learn development activities, all within a forward-thinking and spacious environment while utilising the most advanced technology.

*Business area*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. 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 calculated risks that write the next chapter for our pipeline and Oncology team.

We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early stage cancer trials in the industry, we are getting closer to finding cures every day.

It's our unique people-first approach that keeps us grounded and inspired to improve outcomes for all. Listening to our patients to evolve with their needs and tailor their medicines.

*Come and join our AZ team where you will play a pivotal role in this exciting period of development.*

*What you'll do*
We are looking to recruit experienced Global Study Associates (GSA) to join our Early Oncology Clinical group. 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.

*Key Accountabilities*
* 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.

*Required Experience, Skills, and Qualifications*
*To be considered for this position, you will need to:*

* Have a university degree / Batchelor's degree or equivalent experience
* Possess a basic understanding of the drug development process as well as a basic knowledge of ICH-GCP principles
* Minimum of 1-2 years' experience of administrative / operational support of clinical studies

*Demonstrate the following behaviours;*

* Team orientation
* Ability to coordinate and prioritise multiple tasks and deliverables
* Proactive approach
* High degree of flexibility
* Demonstrated verbal and written communication skills

Making a difference every day by delivering life-changing medicines to millions of people globally, our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a culture that inspires innovation and collaboration. If this sounds like the place for you - don't hesitate to apply and join us to become part of a Great Place to Work!

*Why AstraZeneca*At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

*So, what's next? *

* Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Don't hesitate in submitting an application today.

*Competitive salary and benefits package on offer.*
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.

*Closing date: 17th December 2021*
*Where to find out more:*
Our Social Media, Follow AstraZeneca on LinkedIn []()
Follow AstraZeneca on Facebook []()
Follow AstraZeneca on Instagram []()