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Local Clinical Study Manager - 12 Month FTC

Plats Macquarie Park, New South Wales, Australien Jobb-id R-067363 Datum inlagd 12/04/2019

Local Clinical Study Manager - 12 Month Fixed Term Contract

At AstraZeneca we lead our industry in our development of a strong and varied pipeline. This means our people are here to win. We give you a breadth of opportunities to be curious and do cutting edge, unique work that has big impact on science and medicine.

This couldn’t be more true for our Clinical Research team. Our Clinical Research team are responsible for ensuring that study activities are being carried out in accordance with local and global procedural and regulatory requirements as we look to bring our products to market in a timely manner.

As our new Local Study Manager, you will be responsible for effective study management across a number of high profile studies. This is a broad role where you will be responsible for all aspects of the study from start-up through to close-out. You will work closely with an experienced team focused on delivering best outcomes for AstraZeneca and our patients.

Main Duties and Responsibilities

  • Overall responsibility for study commitments from start-up through to close-out, ensuring timely delivery of high quality data
  • Lead Australian Study Delivery Team through proactive patient recruitment, risk identification/mitigation and study site progress
  • Lead and optimise the performance of the Local Study Teams, consisting of monitors and study administrators, at country level ensuring compliance with ICH-GCP and AZ Procedures
  • Perform any required co-monitoring & QC visits with study monitors
  • Report study progress/strategy to AZ global colleagues.
  • Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
  • Attend and contribute to global or national Investigator meetings.
  • Ensure study is ‘inspection ready’ at all times through proactive management of essential documentation.
  • Liaise and collaborate with AZ medical and commercial colleagues to deliver the R&D pipeline

Essential Requirements

  • Experience working in a similar capacity, with proven track record in proactive study management
  • University degree in related discipline, preferably in life science, or equivalent
  • Fluent knowledge of spoken and written English.
  • Excellent interpersonal and communication skills, along with good negotiation skills and a demonstrated ability to work effectively in a team environment.
  • A strong focus on quality, with an excellent knowledge of international guidelines ICH-GCP
  • Strong prioritisation, problem solving and time management skills
  • Ability to respond quickly to changing priorities and opportunities
  • Highly proficient in computer programs and clinical trial management systems
  • Ability to travel nationally as required. Occasional International travel may also be required.
  • Full working rights (we are not able to sponsor for this role).
  • Experience in Oncology would be beneficial but not essential

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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