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Global Study Leader, Biopharmaceuticals

Местоположение Миссиссога, Онтарио, Канада Идентификатор вакансии R-100593 Дата публикации 02/17/2021

Are you passionate about leading clinical trials and drug development? Join the team that follows the science unlike anywhere else. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs.

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 7 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 Biopharmaceuticals Research and Development Team:

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. It’s a place to think differently – to find new ways of handling and treating diseases. We are trusted and empowered to explore.

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

  • As AZ’s project leader, you will 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 drug 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!

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 authorisation and employment eligibility verification requirements.

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