Biopharma Study Management Operations GSA Intern
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.
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 the role:
The Biopharma Study Management Operations Intern is a member of extended global study team supporting delivery of clinical studies within Global Medicines Development (GMD) to time, cost, and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The intern supports Global Study Associate Director (GSAD) and Global Study Managers (GSM) in delegated aspects of clinical study execution in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework, current clinical trial regulations (e.g., ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and standards (e.g. AZ guidelines) and in line with AZ values and behaviours.
This role is a 12-month paid contract position, which starts in January 2027 and will end in December 2027.
This position will be based in our Mississauga head office and allow for flexible working arrangements working both onsite (3 times per week) and virtually.
Key Responsibilities may include:
- Support Global Study Associate Directors and Global Study Managers by completing delegated study work.
- Initiate and be responsible for the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of
- Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs
- Interact/collaborate with Site Management & Monitoring, other internal staff and external vendors in collection of regulatory and other essential documents.
- Contribute to electronic applications/submissions in ANGEL by crafting and handling clinical regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR
- Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements
- Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint, BOX if used, MS teams and study team shared mailbox) and support team members in the usage of these tools
- Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant partners to fulfil AstraZeneca compliance and meet the regulatory authority needs
- Support the Global Study Leader with tracking, reconciliation and follow-up of the study’s budget/payments in relevant systems (e.g. Coupa, FIND)
- Contribute to application, coordination, supply and tracking of study materials and equipment. Internal BioPharmaceuticals Clinical Operations Job Description
- Contribute to collection of study supplies, if required, at the study close-out
- Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs
- Lead practical arrangements, coordination and assist in preparing meetings both within the organization and with outside parties. Examples include study team, committee, monitor, Investigator, and virtual meetings. Liaise with internal and external participants and/or vendors
- Prepare, contribute and distribute presentation material for meetings, newsletters and web sites
- Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.
Qualifications:
- Education in medical or biological sciences or specialty associated with clinical research preferred;
- Confirmed organizational and analytical skills
- Previous administrative training/experience
- Computer proficiency in day-to-day tasks
- Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with ICH/GCP guidelines
- Excellent verbal and written communication in English
- Demonstrate ability to work independently, as well as in a team environment
- Ability to prepare presentation materials
- Demonstrate professionalism and mutual respect
- Willingness and ability to train others on study administration procedures
- Display excellent organization and time management skills, excellent attention to detail, can multi-task in a high- volume environment with shifting priorities
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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 42,908.00 to 56,316.75.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.