Skip Navigation

Job Title

Job category

Science

Search jobs by matching your skills with LinkedIn

Sign up for job alerts

Or search again

Search by city

Location:
Mississauga, Ontario, Canada
Job reference: R-039875
Posted date: Mar. 05, 2019
Apply

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: Global Study Leader

Position Type: Full-time, Temporary (12 Month Contract)

Career Level: E

Location: Mississauga, Ontario

The Global Study Leader is responsible for leading a cross-functional study team and for providing the team with direction and clear decisions to enable successful delivery of clinical studies from receiving study specifications through to study archiving.

Responsibilities:

  • You will lead a cross-functional team of experts to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality in line with ICH/GCP and AZ relevant SOPs
  • For outsourced studies, you will act as AZ’s project leader and point of contact to the CRO project manager to ensure delivery to time, quality and cost; ensuring that appropriate AZ oversight of the CRO is defined and performed across relevant AZ functions
  • You will develop and maintain relevant study plans (e.g. global study management plan, monitoring plan, etc.) lead study level performance against agreed upon plans, and lead proactive risk and contingency planning and raise issues to stakeholders as appropriate
  • You will provide input and hold accountability for the development of essential study level documents (i.e. Clinical study Protocol)
  • You will provide oversight, mentorship and support to the study team members
  • You will select and lead vendors, overseeing their performance to ensure high quality, timely delivered services
  • You will ensure appropriate training is provided to the local teams, investigators and site staff as well as vendor teams as needed; taking an active role in the Investigators/Monitoring Meetings;
  • You set initial operational study budget with the Clinical Program Team (CPT), and are responsible for study budget throughout the study, providing budget progress reports to CPT
  • You will ensure studies are inspection-ready at all times, according to ICH-GCP, AZ SOP and relevant policies/guidelines
  • You will be responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection
  • You may be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and change management techniques

Minimum Qualifications:

  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
  • At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including clinical trial leadership experience (preferable on global trials)
  • Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas
  • A minimum of 2 years clinical project management experience. PMP certification is desirable but not mandatory.
  • Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing
  • Proven understanding of clinical study budget management
  • Good communication and relationship building skills, including vendor management skills

Interviews

Applicants who meet the minimum requirements as outlined above, will progress in our recruitment process.Internal applicants interested in this position are advised to inform their manager before applying to this role.

AstraZeneca Canada Inc. is an equal opportunity employer in accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, AstraZeneca will provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities. If selected to participate in the recruitment, selection and/or assessment process, please inform the Talent Acquisition Partner of your accommodation(s) need(s) to ensure your equal participation.

Apply
Global Study Leader (12 Month Contract)
Clinical Development

Sign up for job alerts

If you would like to sign up for email job alerts for future roles with AstraZeneca or MedImmune you can do so using the form below. We will only use the details you provide below to inform you about future vacancies that match your search criteria if and when they become available. The details you provide on this page will not be used to send unsolicited communication and will not be sold to a third party.

 

You can select as many categories and locations as you wish.

Interested InSelect a job category from the list of options. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

  • Clinical Development, Mississauga, Ontario, CanadaRemove