Clinical Research Project Manager

6 days ago

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

We are seeking a highly skilled and experienced Clinical Research Project Manager to join our team at Southern Star Research. As a key member of our project management team, you will be responsible for overseeing the planning, execution, and delivery of clinical trials across various therapeutic areas.

Key Responsibilities:

  • Manage all aspects of the trial process, including timelines, budgets, resources, and vendor relationships.
  • Act as the central point of contact for client trial inquiries and provide timely and effective responses.
  • Develop and implement project plans, quality standards, and risk mitigation strategies to ensure successful trial outcomes.
  • Lead cross-functional project teams through all phases of the clinical trial, ensuring effective communication and collaboration.
  • Coordinate sponsor study start-up processes, including kick-off meetings, site selection, and other agreements and budgets.
  • Ensure effective project plans are in place and operational for each trial, adhering to standard operating procedures (SOPs) and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines.
  • Develop and review documents to ensure alignment with SOPs and local regulations.
  • Lead assigned teams in the delivery of contracted project services and provide guidance and support as needed.
  • Train and mentor project team members and other staff to ensure knowledge sharing and skill development.

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 PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region, offering a dynamic and challenging work environment. As a Clinical Research Project Manager, you will have the opportunity to work on a wide range of clinical trials, develop your skills and expertise, and contribute to the success of our organization.

What We Offer:

  • An attractive remuneration and benefits package.
  • Genuine work-life balance and flexibility.
  • Career stability and security.
  • Opportunities for professional growth and development.

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