Clinical Trial Manager - Mississauga, Canada - AstraZeneca

AstraZeneca

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

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Description

Clinical Trial Manager, Global (12 month contract)
**Mississauga, Canada (hybrid work
- average of 3 days in office)**
Competitive salary and benefits

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.

What you'll do:

Act as a member of the extended global study team supporting delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving
Build crossfunctional partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery
Maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery.
Lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications)
Support the Global Study Associate Director (GSAD) in project management as per agreed delegation
Ensure the supply of study materials and Investigational product by collaborating closely with Clinical Supply Chain or external service providers
Support the GSAD with budget management, such as external service provider invoice reconciliation
Ensure studies are inspectionready at all times according to ICH-GCP, AZ SOP and relevant policies/guidelines
Ensure that all study documents in scope of Global Study Manager (GSM)'s responsibilities are completed and verified for quality in the Trial Master File
Assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
Monitor study conduct and progress, identifying and resolving risks and issues which may impact delivery of the study to the quality, timeline or budget objectives with the GSL
Contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics
Ability to provide input into nondrug project work including training activities and the development of procedures as needed
Responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs

Essentials for the role:

University degree (or equivalent), preferably in medical or biological sciences or field associated with clinical research
Minimum 3 years experience within the pharmaceutical industry supporting clinical operations
Project management, organizational and analytical skills
Knowledge of clinical development/ drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP
Computer proficiency
Excellent knowledge of spoken and written English

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