Job Description

Global Study Associate Director, Respiratory and Immunology

Hybrid Work- 3 days/week from our Mississauga office

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Summary

The Global Study Associate Director (GSAD) is a business-critical role within Study Management R&D, Development Operations, whose main accountability is the delivery of clinical studies. You will be responsible for leading a cross-functional study team (core and extended) and providing the team with guidance to enable successful study delivery. You are the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSAD is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

The GSAD leads the study team and/or study oversight team in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework and/or clinical outsourcing model (SCOUT), current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.

What you\xe2\x80\x99ll do:

Responsible for leading a cross-functional study team to enable successful delivery of clinical studies from the onset of study specifications through to study archiving

Mentor and empower a cross-functional team to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality in line with ICH/GCP and AZ relevant SOPs

Be the key point of contact to the CRO project manager to ensure delivery to time, quality and cost; ensuring AZ oversight of the CRO is defined and performed across relevant AZ functions for outsourced studies

Develop and maintain up to date study plans (e.g. global study management plan, monitoring plan, etc.) ensure study level performance against agreed upon plans, lead proactive risk and contingency planning and raise issues as appropriate

Provide input and hold accountability for the development of crucial study level documents (i.e. Clinical study Protocol)

Select and lead vendors, handling their performance to ensure high quality, timely delivered services

Ensure appropriate training is provided to the local teams, investigators and site staff as well as vendor teams as needed; taking an active role in the Investigators/Monitoring Meetings

Set initial operational study budget with the Clinical Program Team (CPT), and are responsible for study budget throughout the study, providing budget progress reports to leadership

Ensure studies are inspection-ready at all times, according to ICH-GCP, AZ SOP and relevant policies/guidelines

Responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection

May be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and to inspire change for new ways to work

You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures

Essentials for the role:

University degree (or equivalent), preferably in medical or biological sciences or related to clinical research. Advanced degree is preferred.

At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including clinical trial leadership experience (preferably on global trials)

Solid understanding of clinical operations and study management processes, along with experience in various phases of development and therapy areas

A minimum of 2 years clinical project management experience. PMP certification is desirable.

Possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, empowering critical thinking, problem solving, and influencing

Significant experience managing study budgets

Strong communication skills with the ability to build positive relationships, including vendor leadership skills

Great People Want to Work with Us! Find out why:

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted 04-Aug-2023

Closing Date 17-Aug-2023

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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