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

Our values guide everything we do at AstraZeneca. They power our belief in What Science Can Do – a belief in its potential to redefine what’s possible. It’s our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before.

If your passion is science and you want to be part of a team that makes a bigger impact on patients’ lives, then there’s no better place to be.

What you’ll do

• Approve sites for drug shipment

• Prepare, execute, track, collect, review and assess clinical documents while ensuring their completeness according to regulatory guidelines

• Assist external investigational site staff with the accurate and timely completion of ethics and regulatory documents in accordance with the regulatory and GCP guidelines

• Review the study scope and design to provide input into the site level activation and risk mitigation plan and give ongoing study/site level problem solving throughout the study

• Support the study lead, by reviewing and contributing to the development and preparation of all study/site level documents as required (for example: Study Management Agreements, delegation of responsibility, Clinical Study Agreements, etc.)

• Support the study regulatory and ethics submission process

• Ensure audit readiness, by conducting quality checks of SMF documents according to the study Quality Control Plan

• Plan and actively collate the appendices for the CS Report

• Develop training material and train site personnel, local study team, research monitors, etc., on study-specific clinical supply and documentation matters (as needed)

• Contribute to the vendor selection and management process where appropriate

• Set-up, populate, update and accurately maintain information in AstraZeneca clinical systems (e.g. Clinical Trial Management system, eRoom, study web pages, payment application, etc.)

• Input and review payment terms and fee schedule of the Clinical Study Agreement.

• Review, assess, approve and process payments associated with Agreements, to be in line with the terms of the agreement and financial guidelines

• Set up and maintain payment terms within the appropriate systems.

• Review, analyze and resolving payment discrepancies and queries

• Lead non-drug supplies, by developing, inputting into, sourcing, ordering, initiating the shipment, tracking, reviewing stock level, and approving materials for destruction

• Handle import shipping approvals

• Prepare and execute Statement of Work (SOW) with vendor for local drug management

• Collaborate with Global Investigational Product Supplies units to ensure precise delivery of clinical drug supplies

• Communicate with global study teams and local regulatory contacts, to assess Canadian requirements for comparator and/or rescue medication, and source from local providers if required

• Review, discuss, and communicate packaging and labelling requirements, as defined by the protocol, with vendors

• Responsible for the notification, investigation and resolution of product quality complaints

Essentials for the role:

• University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered)

• Two years’ experience in Clinical Research or related industry

• Understanding of Good Clinical Practices/International Committee on Harmonization principles

• Strong social and interpersonal skills (written and oral). You will be confident speaking to Health Care Professionals.

• Ability to influence without authority

• Ability to effectively both independently and in a team environment

• Self-motivated and able to display autonomy and initiative

• Strong attention to detail with exceptional project management skills

• Effective time management skills

• Passion for customer service

• Good knowledge of MS Office (Word, Excel, PowerPoint) using multiple computer systems

• Bilingual in French would be considered an asset.

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.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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.