Study Delivery Associate 12 Month Contract

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.

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 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

• French speaking considered an asset.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 11 years

• Top 100 Employers Award

• Canadas Most Admired Corporate Culture

• Learn more about working with us in Canada

• View our YouTube channel

Are you interested in working at AZ apply today!

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.

#LI-Hybrid

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 candidates skills and experience job-related knowledge and other specific business and organizational 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.