Global Clinical Project Lead

OPIS; Australia; On-site; AUD 120,000 - 170,000; Full time

Job summary

OPIS is seeking a proactive Clinical Project Manager in Australia to oversee local and international clinical studies. You will lead internal study teams, manage timelines, budgets, and vendor deliverables, ensuring TMF/eTMF compliance and strong sponsor relationships.

Reporting to the Clinical Operations Manager, you will coordinate resources, monitor sites, and mitigate risks while maintaining high-quality updates for international stakeholders. On-site monitoring may be required as needed.

Qualifications

• A University degree in a scientific field.
• A minimum of 2 years of prior experience as a CRA.
• Excellent command of ICH-GCP and ISO 14155 standards.
• Strong ability to manage and coordinate resources independently.
• Fluent in English (written and verbal) with the ability to provide clear, efficient updates to international stakeholders.
• Willingness to perform on-site monitoring visits as a backup or for quality oversight when required.

Responsibilities

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

Skills

Resource coordination

Project leadership

Regulatory knowledge

English communication

Independent work ethic

Education

University degree in a scientific field

Tools

CTMS familiarity

Job description

OPIS is seeking a proactive Clinical Project Manager in Australia to oversee local and international clinical studies. You will lead internal study teams, manage timelines, budgets, and vendor deliverables, ensuring TMF/eTMF compliance and strong sponsor relationships.

Reporting to the Clinical Operations Manager, you will coordinate resources, monitor sites, and mitigate risks while maintaining high-quality updates for international stakeholders. On-site monitoring may be required as needed.