Clinical Trial Project Managers

• Full time (1 FTE) opportunities
• 2 year, fixed term contract
• Hybrid working arrangements available, with a combination of office and virtual work
• Respected global research organisation
• Make an impact on global health outcomes
• Fantastic culture

The George Institute (TGI) is 700+ people around the world, all focused on improving the health of millions of people worldwide. As a medical research institute affiliated with leading universities and with projects in approximately 50 countries, we are challenging the status quo in healthcare to:

• Find better treatments for the world's biggest health problems
• Transform primary health care to support better health for more people
• Harness the power of communities, governments and markets to improve health

Our innovative commercial enterprises help maximise our impact. Please visit 'what we do' to read more about how we are addressing the world's biggest health problems.

We now have new and exciting opportunities for Clinical Trial Project Managers to join the academic project operations (APO) team.

The APO team work closely with our research teams, and is primarily responsible for the set-up, conduct and overall delivery of a projects across all research programs at TGI, according to best practice guidelines and research budgets.

The Project Manager (PM)  will drive, manage and deliver clinical research projects from start-up to close-out. Leadership, problem solving, critical thinking, teamwork and flexibility are key attributes required to undertake this role in a busy global academic research environment.

Key Responsibilities

• Deliver project specific milestones and budgets, and continuously monitor project progress, reporting to stakeholders as required
• Manage all aspects of the project(s) including but not limited to:
  • Development of the project plan and requirements including statistics, data management, safety & quality
  • Budget development and management
  • Contract negotiations and management
  • Stakeholder engagement and management
  • Committee management including operations, steering and data safety & monitoring committees
  • Project communications and reporting
  • Team management and mentorship
  • Site and / country feasibility and selection
  • Study medication planning and management
  • Quality management including oversight of monitoring activities
  • Safety management in accordance with regulatory requirements
  • Compliance with all ethical & regulatory requirements and organisational SOPs

The key skills and experience the PM will bring include:

• Extensive experience in project management of complex intervention clinical trials with academic, pharmaceutical, CRO, biotechnology and/or medical device background
• Comprehensive practical knowledge, understanding and ability to apply GCP, Australian and international ethical and regulatory requirements in context
• Excellent technical document writing skills e.g. project plans, procedure manuals, standard operating procedures, participant facing documents
• Project budget development and management
• Ability and flexibility to work in an international environment
• Highly collaborative with strong stakeholder management skills
• Excellent problem-solving skills
• Experience and skills in team leadership
• Therapeutic knowledge in one or more chronic disease areas e.g. renal, neurology, cardiovascular & diabetes.
• Full Australian working rights

This is a great opportunity for you to work on exciting projects and make an impact on global health outcomes.

The closing date for applications is midnight, Friday 2nd September, 2022.

We do, however, reserve the right to close this vacancy early if a suitable candidate is found.