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Global Study Associate Director, Oncology

Location Mississauga, Ontario, Canada Job ID R-145170 Date posted 21/09/2022

Are you passionate about leading clinical trials and drug development? Be part of the team that follows the science to transform the lives of patients living with cancer. There is no better place to make an impact, join AstraZeneca today!

About AstraZeneca:

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

 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. Always committed to lifelong learning, growth and development.

AstraZeneca Canada

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 8 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.

Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.

Our Oncology Research and Development Team

Oncology is driven by speed. Here you will be backed by leadership and empowered at every level to prioritize and make bold moves. Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs.

Join a dedicated Oncology team that’s growing fast and building a strong track record of success. We make bold moves at the cutting-edge. Transforming molecules to change the practice of medicine.  

What you’ll 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

Why AstraZeneca?

This is the place to make a meaningful impact – on patients’ lives and your personal growth. It’s both rewarding and inspiring, and it’s what keeps us motivated every day.

Great People want to Work with us! Find out why:

Are you interested in working at AZ, apply today!

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.