Project Manager / Senior Project Manager – Clinical Trials

About the role

Southern Star Research is seeking an experienced Project Manager or Senior Project Manager to lead Phase I and II clinical studies across a variety of therapeutic areas. The role offers flexibility to work from the North Sydney office, a hybrid setting, or remotely from anywhere in Australia.

Key responsibilities

• Manage trial timelines, budgets, resources and vendor relationships.
• Serve as the primary contact for client enquiries throughout the study.
• Develop and maintain detailed project plans, quality standards and risk‑mitigation strategies.
• Lead cross‑functional teams through all trial phases, including start‑up activities such as kick‑off meetings and site selection.
• Ensure compliance with SOPs, ICH/GCP guidelines and local regulations.
• Oversee document development, review and alignment with operational procedures.
• Train and mentor project team members as required.

Required profile

• Minimum 5 years of experience in clinical research within a pharmaceutical company, CRO or similar setting.
• At least 2 years of experience as an independent Project Manager, preferably managing Phase I studies.
• Strong understanding of therapeutic indications relevant to clinical trials.
• Ability to work independently and manage multiple projects simultaneously.
• Relevant tertiary qualifications in medical, pharmaceutical or healthcare disciplines (MSc or PhD preferred).

Required skills

• ICH‑GCP knowledge.
• Clinical trial management.
• Project planning and budgeting.
• Vendor management.
• Risk mitigation and quality assurance.