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Clinical Trials Project Manager

2 months ago


Brisbane, Queensland, Australia Southern Star Research Full time
About the Role

We are seeking a highly skilled and experienced Clinical Trials Project Manager to join our team at Southern Star Research. As a key member of our project management team, you will be responsible for leading and managing clinical trials from start to finish, ensuring timely and successful delivery of projects.

Key Responsibilities
  • Proactively manage all aspects of the trial process, including trial timelines, budgets, resources, and vendor relationships.
  • Act as the central point of contact for all client trial enquiries and provide exceptional customer service.
  • Prepare and manage project plans, implement quality standards, and risk mitigation strategies as required.
  • Manage a cross-functional project team through all phases of the clinical trial.
  • Lead sponsor study start-up process, including kick-off meetings, site selection, and other various agreements and budgets.
  • Ensure effective project plans are in place and operational for each trial within trial appropriate SOPs and ICH/GCP guidelines.
  • Develop and review documents to ensure alignment with standard operation procedures and local regulations.
  • Lead assigned team/s in the delivery of contracted project services.
  • Train and mentor project team members and other staff as needed.
Requirements
  • Minimum 5 years of experience working in clinical research in a pharmaceutical company, CRO, or other research setting.
  • 2+ years of experience as an independent Project Manager.
  • HV, Oncology, and/or Radio-Oncology experience is preferred.
  • International Project Management Experience across APAC and US is preferred.
  • A solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials.
  • A sound knowledge and understanding of ICH-GCP.
  • Exposure to a broad range of trials across multiple therapeutic areas.
  • Ability to work independently.
  • Appropriate tertiary qualifications in the medical, pharmaceutical, or healthcare disciplines (MSc or Ph.D. is highly desirable).
Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region, and this is an ideal opportunity for someone who is looking to be involved in all aspects of clinical trials across a range of different therapeutic areas and progress their skills in project management.

We offer a dynamic and supportive work environment, with opportunities for career growth and development. Our team is passionate about delivering high-quality clinical trials, and we are committed to providing our employees with the resources and support they need to succeed.