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Job Description:

About AstraZeneca

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 entrepreneurial thinking and act with a sense of urgency We are courageous, taking smart 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 life-changing medicines

Position Title Study Delivery Associate

Position Type Full-time, Contract - 12 Months

Career Level C

Location Mississauga, Ontario

Are you highly organized and take pride in your attention to detail Are you passionate about a career that brings new medicines to patients Do you easily build positive relationships with people and have an affinity for following process

The Study Delivery Associate is a member of the extended Local study team and supports the successful delivery of Local and Global studies and projects

Your responsibilities include

You will actively and effectively deliver study activities to ensure quality, compliance and consistency of deliverables to time, cost and quality objectives
You will build and maintain effective professional relationships with the your team and external investigative site staff
You act as the primary contact for clinical supply matters, ethics/regulatory documentation requirements and payments, to both internal and external customers
You approve sites for drug shipment
You prepare, execute, track, collect, review and assess clinical documents and ensure their completeness
You review the study scope and design, in order to provide input into the site level activation and risk mitigation plan and resolve study related issues or problems
You assist the study lead, by reviewing and contributing to the development and preparation of all study/site level documents as required
You support the study regulatory and ethics submission process
You lead ethics and regulatory documents for site renewals
You ensure audit readiness, by conducting quality checks of study documents according to the study Quality Control Plan
You plan and compile the appendices for the Clinical Study Report
You develop training material and train site personnel, your team, research monitors, etc, on study-specific clinical supply and documentation matters (as needed)
You assist with the vendor selection and management process where appropriate
You set-up, populate, update and accurately maintain information in AstraZeneca clinical systems

Study Drug & Non- Drug Supplies Responsibilities

You lead non-drug supplies, by developing, providing input, sourcing, ordering, approving and initiating the shipment, tracking, reviewing stock level, and approving materials for destruction
You prepare and execute Statement of Work (SOW) and own the activities with vendor for local drug management
You collaborate with Global Investigational Product Supplies units to ensure flawless delivery of clinical drug supplies
You 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
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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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