Expert Clinical Trial Start-Up Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeClinical Full time $115,030 - $127,995
Job Description

As a specialist in clinical trial start-up, you will play a pivotal role in the management of clinical trials at Macquarie University. This is an exciting opportunity to contribute to the advancement of medical research and develop your expertise in the field.

The successful candidate will be responsible for providing strategic start-up and regulatory advice and support for sponsored and investigator-initiated Phase I-IV clinical trials. You will lead a team of associates and provide expertise on research ethics or integrity issues and clinical trial regulations.

Your key responsibilities will include:

  • Leadership and Strategy: Contribute to strategic planning, team culture, and leadership of the Clinical Trials Unit; provide strategic business partnering and decision-making support for start-up and regulatory matters.
  • Clinical Trial Regulatory Oversight and Support: Provide advice on research ethics or integrity issues and clinical trial regulations; oversee MQ clinical trial HREC and governance submissions; ensure MQ clinical trial documentation is compliant with GCP and legislative requirements.
  • People Management: Develop, lead, and manage a high-performing team through staff development, performance management, goal setting, and skills development; promote a culture of constructive feedback and foster a safe environment for communication.
  • Stakeholder Management: Identify key stakeholders and build relationships to drive building strategic clinical trials portfolios.
Required Skills and Qualifications

We are seeking a proactive, caring, and supportive manager with a track record of inspiring and developing a team. You will have excellent working knowledge of clinical trials and experience in developing and implementing processes to support streamlined clinical trial start-up, feasibility, and regulatory activities across multiple therapeutic areas.

Benefits

This position offers the opportunity to work in a dynamic and innovative environment, contributing to the advancement of medical research. You will have the chance to develop your skills and expertise, working with a talented team of professionals.

Others

The Clinical Trials Unit is part of the Faculty of Medicine, Health, and Human Sciences at Macquarie University. Our team undertakes sponsored and investigator-initiated Phase I-IV trials across multiple therapeutic areas with multiple principal investigators. We value teamwork and innovation and are committed to advancing medical research.

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