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Local Study Manager

Location Mississauga, Ontario, Canada Job ID R-085814 Date posted 07/08/2020

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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 day, we make a difference by delivering 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 an inspiring culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We take risks and learning from both success and failure. We are 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.

Position title: Local Study Manager

Position Type: Contract (12 months), Permanent

Location: Mississauga, Ontario

Career Level: E

Description:

You will lead and coordinate to the global clinical studies to ensure quality, consistency, and integration of Canadian study data and progress operational deliverables to time, cost and quality from study start through study close-out activities. You work with internal and external partners, on studies across various phases of drug development and various therapy areas.

Accountabilities/Responsibilities:

  • Plan and deliver local commitment of global clinical studies to the agreed time, budget and scope
  • Coordinate and lead local study team meetings
  • Develop or provide study related input to local and global study documents including clinical study protocols, consent forms, source data verification plans, data management plans, risk management plans and recruitment action plans
  • Develop, coordinate and deliver study training for the local study team members, site monitors and possibly investigators
  • Lead site start-up activities including ethics submission, informed consent review, development and finalization of clinical study agreements, site specific budget negotiations, site system set-ups, site vendor set-up, recruitment expectations, and follow-up and maintenance of all study activities
  • Develop and maintain study budget, study timelines, and study resources and update tracking systems appropriately
  • Coordinate data management activities, such as query resolution, SDV and timelines for final data entry
  • Plan and lead activities associated with audits in liaison with clinical quality assurance.

Minimum Requirements – Education and Experience

  • Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
  • Experience working on clinical studies
  • At least 5 years experience from within the pharmaceutical industry or similar organization or academic experience.
  • Extensive knowledge of clinical operations, project management tools and processes
  • Proven organizational and analytical skills

Skills and Capabilities

  • Excellent interpersonal skills and demonstrated ability to work and lead cross-functional teams with internal and external partners
  • Demonstrated Project Management skills
  • Displays excellent organization and time management skills, high level attention to detail, and ability to work in a high volume environment with shifting priorities
  • High level of understanding of clinical data flow
  • Excellent verbal and written communication and presentation skills
  • Demonstrates sound knowledge of GCP, procedural documents, as they pertain to study delivery systems and processes
  • Proactively identifies risks, issues and possible solutions
  • Demonstrates high standards and uses tactful persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships
  • Develops core knowledge of therapy areas for responsible studies
  • Demonstrates professionalism and mutual respect
  • Willingness to travel both domestically and internationally.
  • Knowledge of Oncology is an asset

Great People want to Work with us, you can find out why:

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.