Clinical Trials Manager

20 hours ago

Australia ClearCompany Full time
About the Opportunity

We are seeking a highly motivated and experienced Clinical Trials Lead to join our team at InsideOut Institute. As the operational lead for clinical trials and associated studies, you will be responsible for planning, managing, and executing clinical trials, ensuring streamlined operations, compliance with ethical and regulatory standards, and alignment with clinical objectives.

Key Responsibilities:

  • Lead the planning, management, and execution of clinical trials, ensuring timely conduct and high-quality results.
  • Oversee trial protocols, ethics applications, and engage with stakeholders to ensure effective trial execution across multiple sites.
  • Champion Good Clinical Practice (GCP) across all trial sites, driving consistency in ethical and scientific rigour while managing reporting, risk assessment, and compliance.
  • Manage work area resources, including budgeting, financials, personnel, and technology, to support service delivery and operational success.
  • Lead and develop staff by providing clear direction, managing performance, and fostering professional growth within the team.
  • Provide senior management support, collaborate with internal teams, and contribute expertise on clinical trials, while managing ad-hoc projects as needed.

About You

  • Post-graduate qualifications in Health, Psychology, or a relevant field.
  • Extensive experience in clinical trial management and coordination, including regulating complex, multi-site biomedical research with a large human subjects component.
  • Strong knowledge of ICH Guidelines, Good Clinical Practice (GCP), and regulatory compliance, with the ability to develop and maintain SOPs for clinical trials.
  • Proficient in project management, process streamlining, and coordination in research-intensive environments, with excellent leadership skills to drive change in complex settings.
  • Excellent interpersonal, verbal, and written communication skills, with expertise in report writing, conflict resolution, and negotiating while maintaining high ethical standards and business integrity.
  • Proficiency in using clinical trial management software and databases, such as EDC systems, CTMS, and statistical analysis tools, to support trial execution, data analysis, and reporting.
  • Strong problem-solving, analytical, and time management skills, with the ability to meet conflicting deadlines in high-pressure environments.
  • Ability to travel for conferences or meetings (desirable).

Requirements

  • Valid work rights for Australia.
  • Working with Children Check clearance.

How to Apply

Applications can be submitted via the Apply button at the top of the page. For employees of the University or contingent workers, please login into your Workday account and navigate to the Career icon on your Dashboard. Click on USYD Find Jobs and apply.

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