Global Clinical Project Lead

OPIS; Australia; On-site; AUD 110,000 - 150,000; Full time

Job summary

OPIS is seeking a proactive Clinical Project Manager to oversee local and international clinical studies. You will drive study teams, ensure on-time, on-budget delivery while complying with global regulatory standards.

Reporting to the Clinical Operations Manager, you will manage the full lifecycle of clinical investigations and collaborate across functions. Key responsibilities include leading study teams, managing timelines and budgets, ensuring proper TMF/eTMF documentation, and coordinating

Qualifications

• Minimum 2 years' experience as a Clinical Research Associate (CRA).
• Experience in project coordination is valued.
• Solid knowledge of ICH-GCP and ISO 14155.

Responsibilities

• Lead the study team, organize kick-off meetings and act as the primary contact for Sponsors and Investigators.
• Manage trial timelines, budgets, and vendor deliverables; oversee IMP/MD supplies and study materials.
• Ensure all study documentation is filed in the TMF/eTMF and that monitoring aligns with the Monitoring Plan.
• Oversee site feasibility and qualification; conduct site visits and co-monitoring with CRAs when needed.
• Proactively identify risks and implement timely solutions to keep enrollment and milestones on track.
• Forecast resources and review vendor invoices to ensure all billable activities are captured.

Skills

Project coordination

Resource management

Stakeholder communication

On-site monitoring

Education

University degree in a scientific field

Tools

TMF/eTMF systems

Job description

OPIS is seeking a proactive Clinical Project Manager to oversee local and international clinical studies. You will drive study teams, ensure on-time, on-budget delivery while complying with global regulatory standards.

Reporting to the Clinical Operations Manager, you will manage the full lifecycle of clinical investigations and collaborate across functions. Key responsibilities include leading study teams, managing timelines and budgets, ensuring proper TMF/eTMF documentation, and coordinating