Global Study Manager, Biopharmaceuticals (12 Month Contract)

Do you have expertise in and passion for delivering clinical studies? Would you like to apply your expertise to help patients 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, 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.

What you’ll do:

• You are a member of the extended global study team supporting delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving.

• You will work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery

• You will maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery.

• You will lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications)

• You will support the Global Study Associate Director (GSAD) in project management as per agreed delegation

• You ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers

• You help support the GSAD with budget management, such as external service provider invoice reconciliation

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

• You will ensure that all study documents in scope of GSM’s responsibilities are completed and verified for quality in the Trial Master File

• You will assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)

• You will monitor study conduct and progress, identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the GSAD

• You will contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics

• You will have the opportunity to provide input into non-drug project work including training activities and the development of procedures as needed

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

Essentials for the role:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research

• Minimum 3 years experience within the pharmaceutical industry supporting clinical operations

• Shown project management, organizational and analytical skills

• Knowledge of clinical development / drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP

• Computer proficiency

• Excellent knowledge of spoken and written English

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:

• GTAA Top Employer Award for 7 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada

• Learn more about our culture:https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G

• Browse AstraZeneca's YouTube channel to find out more about us: https://www.youtube.com/user/astrazeneca

Are you interested in working at AZ, apply today!

Date Posted

Closing Date

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.