At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Introduction to role
Are you ready to orchestrate site activation, regulatory readiness and clinical supplies so investigative medicines reach patients faster? Do you thrive at the intersection of regulatory rigor, operational detail and cross-functional collaboration? As an SDA, you will be central to launching and sustaining high-quality clinical studies. You will enable shipment of study drugs by ensuring sites are ready, documentation is complete and audit-ready, vendors are aligned, and financial flows are accurate and timely. Your work will remove barriers before they surface, de-risk country-level execution and keep studies moving with pace and precision. You will collaborate across global and local teams, vendors and investigational sites to translate protocol requirements into practical, compliant operations. In this role, the impact is tangible: faster site activation, uninterrupted supply to patients and clean data that advances a transformative pipeline.
Accountabilities
Responsible for approving sites for drug shipment.
Prepare, execute, track, collect, review and assess clinical documents and ensure 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 contribute to 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: Quality Control Plan, Study Management Agreements, delegation of responsibility, Clinical Study Agreements, etc.)
Contribute to the study regulatory and ethics submission process.
Manage ethics and regulatory documents for site renewals.
Ensure audit readiness, by conducting quality checks of SMF documents according to the study Quality Control Plan.
Plan and proactively collate the appendices for the Clinical Study 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 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 the payment terms and fee schedule of the Clinical Study Agreement.
Review, assess, approve and process payments associated with Clinical Study Agreements, ensuring accordance with the terms of the agreement and financial guidelines.
Set up and maintaining the payment terms within the appropriate systems.
Review, analyze and resolving payment discrepancies and queries.
Manage non-drug supplies, by developing, inputting into, sourcing, ordering, initiating the shipment, tracking, reviewing stock level, and approving materials for destruction
Coordinate or execute import shipping approvals.
Prepare and execute Statement of Work (SOW) with vendor for local drug management.
Mange, coordinate and oversee the activities of the local drug management vendor ensuring accordance with the SOW.
Collaborate with Global Investigational Product Supplies units to ensure seamless delivery of clinical drug supplies.
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.
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.
Essential Skills/Experience
University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered).
Two Minimum years of experience in Clinical Research or related industry.
Understanding of Good Clinical Practices/International Committee on Harmonization principles.
Strong interpersonal and communication skills (written and oral). Especially need to be comfortable with speaking to Health Care Professionals.
Ability to influence without authority.
Able to work effectively both independently and in a team environment.
Self-motivated and able to display autonomy and initiative – for instance; able to take action, move actions forward and make decisions without the need for continual supervision or consultation.
Strong attention to detail.
Ability to manage multiple demands/projects simultaneously.
Effective time management skills.
Solid Customer Service orientation.
Good knowledge of MS Office (Word, Excel, PowerPoint).
Comfortable with technology and using multiple computer systems.
Desirable Skills/Experience
Great People want to Work with us! Find out why:
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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].
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Annual base salary for this position ranges from 81,684.80 to 107,211.30.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
