About AstraZeneca:

At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.

Our purpose is bold and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver life-changing medicines.

Position Title: Study Delivery Associate

Position Type: Full-time, Contract - 12 Months

Career Level: C

Location: Mississauga, Ontario

Are you highly organized and take pride in your attention to detail? Are you passionate about a career that brings new medicines to patients? Do you easily build positive relationships with people and have an affinity for following process?

The Study Delivery Associate is a member of the extended Local study team and supports the successful delivery of Local and Global studies and projects.

Your responsibilities include:

• You will actively and effectively deliver study activities to ensure quality, compliance and consistency of deliverables to time, cost and quality objectives
• You will build and maintain effective professional relationships with the your team and external investigative site staff
• You act as the primary contact for clinical supply matters, ethics/regulatory documentation requirements and payments, to both internal and external customers
• You approve sites for drug shipment
• You prepare, execute, track, collect, review and assess clinical documents and ensure their completeness
• You review the study scope and design, in order to provide input into the site level activation and risk mitigation plan and resolve study related issues or problems
• You assist the study lead, by reviewing and contributing to the development and preparation of all study/site level documents as required
• You support the study regulatory and ethics submission process
• You lead ethics and regulatory documents for site renewals
• You ensure audit readiness, by conducting quality checks of study documents according to the study Quality Control Plan
• You plan and compile the appendices for the Clinical Study Report
• You develop training material and train site personnel, your team, research monitors, etc., on study-specific clinical supply and documentation matters (as needed)
• You assist with the vendor selection and management process where appropriate
• You set-up, populate, update and accurately maintain information in AstraZeneca clinical systems

Study Drug & Non- Drug Supplies Responsibilities:

• You lead non-drug supplies, by developing, providing input, sourcing, ordering, approving and initiating the shipment, tracking, reviewing stock level, and approving materials for destruction
• You prepare and execute Statement of Work (SOW) and own the activities with vendor for local drug management
• You collaborate with Global Investigational Product Supplies units to ensure flawless delivery of clinical drug supplies
• You collaborate and 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
• You review, discuss, and communicate packaging and labelling requirements, as defined by the protocol, with vendors
• You are responsible for the notification, investigation and resolution of product quality complaints

Your qualifications include:

• University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered)
• Minimum two years’ of experience in Clinical Research or related industry
• Deep understanding of Good Clinical Practices/International Committee on Harmonization principles
• Adept at building positive relationships and good communication skills (written and oral), able to converse with key decision makers
• Ability to influence without authority
• Ability to work effectively both independently and in a team environment.
• Self-motivated and able to display autonomy and initiative – for instance; ability to take action by moving actions forward and making decisions without the need for continual supervision or consultation.
• Good detail orientation
• Effective time management skills with the ability to manager multiple demands/projects at a time
• Demonstrate professional customer service orientation
• Good knowledge of MS Office applications (Word, Excel, Outlook, PowerPoint) and agile to learn new systems
• French speaking considered an asset

Interviews:

Applicants who meet the minimum requirements as outlined above, will progress in our recruitment process. Internal applicants interested in this position are advised to inform their manager before applying to this role.

AstraZeneca Canada Inc. is an equal opportunity employer in accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, AstraZeneca will provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities. If selected to participate in our process, please inform the Talent Acquisition Partner of your accommodation(s) need(s) to ensure your equal participation.

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.