Clinical Trial Manager

3 weeks ago

Epsom, Surrey, United Kingdom The University of Queensland Full time
About This Opportunity

We are seeking an experienced Clinical Trial Manager to join our team at The University of Queensland. In this role, you will provide specialized project management and clinical trial management skills for a national, multi-site, randomized clinical trial.

Key Responsibilities
  • Ensure the highest standards of trial management, research governance, and ethics compliance
  • Develop, monitor, and report on the project plan for the trial
  • Draft trial-specific protocols and processes
  • Collaborate with internal and external stakeholders to ensure successful trial execution
  • Develop and manage research project documents, including ethics and governance submissions, study protocols, and case report forms
  • Perform clinical data review listings and summary tables, including query generation and resolution management
  • Establish a project governance framework involving parties from the University, Queensland Health, and other trial partners
  • Work with onsite staff at partner hospitals and universities to establish and support ongoing operation of trial sites in accordance with SOPs, protocol, and applicable regulatory guidelines
  • Develop clinical trial project documentation, including the Trial Master File (TMP), operating procedures, protocols, and site initiation documentation
  • Monitor budgets and support the Chief Investigator with project finances
  • Maintain communication with collaborators, trial sites, and key stakeholders, including organizing and actively participating in meetings and trainings
About You
  • Postgraduate tertiary qualifications, preferably in a science or healthcare discipline, or relevant senior experience working in a science or healthcare setting
  • Previous and relevant experience working on clinical research projects within an academic, CRO, or pharmaceutical environment
  • Strong experience in project management and conducting complex multi-site clinical trials in accordance with GCP methodology, including evidence of management of project budgets exceeding $1 million
  • Experience in feasibility analyses, budget management, site start-up, and all aspects of trial management through to close-out activities
  • Demonstrated knowledge of Australian and international regulatory requirements for clinical trials and clinical research
  • Highly collaborative with good stakeholder management skills, strategic thinking, and analytical skills, along with strong organizational, communication, and planning skills
  • Excellent interpersonal skills and the ability to work well and flexibly with a wide range of stakeholders
  • Experience with the Redcap Database
  • Previous experience with clinical site initiations and clinical site monitoring
  • Strong focus on quality of work
  • Proficient in the use of the Microsoft Office suite and clinical trial management systems, with the ability to learn new systems as required

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