Global Clinical Project Lead: Timelines & Compliance

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

Benefits offered by this job

Competitive salary + benefits

Job summary

OPIS is seeking a proactive Clinical Project Manager to oversee local and international clinical studies. Reporting to the Clinical Operations Manager, you will drive study teams to deliver projects on time, within budget, and in full regulatory compliance.

You will manage the full lifecycle of clinical investigations, lead cross-functional groups, monitor timelines and budgets, ensure TMF/eTMF accuracy, and maintain strong sponsor and vendor relationships.

Qualifications

• A University degree in a scientific field.
• Minimum of 2 years of prior experience as a Clinical Research Associate (CRA).
• Experience in project coordination is highly valued.
• Excellent command of ICH-GCP and ISO 14155 standards.

Responsibilities

• Lead the study team, organize kick-off meetings, and act as 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 (SIV, MV, COV) as needed and co-monitor with CRAs.
• Identify risks and implement timely solutions to keep enrollment curves and milestones on track.
• Forecast resource needs and review vendor invoices to ensure all billable activities are captured.

Skills

Resource coordination

Team coordination

English communication

Education

University degree in a scientific field

Tools

ICH-GCP

ISO 14155

Job description

OPIS is seeking a proactive Clinical Project Manager to oversee local and international clinical studies. Reporting to the Clinical Operations Manager, you will drive study teams to deliver projects on time, within budget, and in full regulatory compliance.

You will manage the full lifecycle of clinical investigations, lead cross-functional groups, monitor timelines and budgets, ensure TMF/eTMF accuracy, and maintain strong sponsor and vendor relationships.