Study Delivery Associate

AstraZeneca - Mississauga, ON (30+ days ago)

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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 ambitious thinking and act with a sense of urgency. We are courageous, taking 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 medicines. We believe science and patients are at the heart of our work, every day.

Position Title: Study Delivery Associate

Position Type: Contract, Full-Time (12 month)

Career Level: C

Location: Mississauga

Are you ambitious and dedicated in nature, with a passion for customer engagement and putting patients first? Are you resilient and play to win; doing the right thing and acting with integrity, even in difficult situations? Do you want to join a culture that is science and patient-focused, agile and high-performing, focused on building opportunities to improve patient care?

Your responsibilities include:
You approve sites for drug shipment
You prepare, execute, track, collect, review and assess clinical documents and ensure their completeness according to regulatory guidelines.
You assist external investigational site staff with the accurate and timely completion of ethics and regulatory documents in accordance with the regulatory and GCP guidelines.
You review the study scope and design, to provide input into the site level activation and risk mitigation plan and give to ongoing study/site level problem solving throughout the study
You 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.)
You aid in the study regulatory and ethics submission process
You ensure audit readiness, by conducting quality checks of SMF documents according to the study Quality Control Plan
You plan and actively collate the appendices for the CS Report
You develop training material and train site personnel, local study team, research monitors, etc., on study-specific clinical supply and documentation matters (as needed)
You are part of the vendor selection and management process where appropriate
You 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)
You input and review payment terms and fee schedule of the Clinical Study Agreement.
You review, assess, approve and process payments associated with Agreements, to be in line with the terms of the agreement and financial guidelines
You set up and maintain payment terms within the appropriate systems.
You review, analyze and resolving payment discrepancies and queries
You will lead non-drug supplies, by developing, inputting into, sourcing, ordering, initiating the shipment, tracking, reviewing stock level, and approving materials for destruction
You handle import shipping approvals
You prepare and execute Statement of Work (SOW) with vendor for local drug management
You collaborate with Global Investigational Product Supplies units to ensure precise delivery of clinical drug supplies
You 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)
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.
You are able to influence without authority
You work effectively both independently and in a team environment
You are self-motivated and able to display autonomy and initiative
You apply a strong attention to detail
You seek multiple demands/projects simultaneously
Effective time management skills
Your passion lies in customer service
You have good knowledge of MS Office (Word, Excel, PowerPoint) d using multiple computer systems
Being bilingual in French would be considered an asset.

Next steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager will know that you feel well qualified for this position. If you know someone who would be a great fit, please share this posting with them.

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.

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