Clinical Project Lead — 12‑Month Medical Devices

Abbott; Sydney; On-site; AUD 85,000 - 120,000; Full time

Job summary

Abbott in Sydney is seeking an experienced Clinical Study Coordinator for a 12-month contract. The role focuses on coordinating designated regional clinical study programs, overseeing budgets and logistics, and ensuring compliance with ICH GCP and local regulations.

You will liaise with investigators, CROs, and Abbott stakeholders to deliver trials on time and within scope. The role requires strong monitoring experience, solid MS Office skills, and the ability to work across multiple sites.

Qualifications

• 5+ years in medical devices or combined med device/pharma with at least 2 years monitoring.
• Knowledge of ICH GCP Guidelines and implementation.
• Knowledge of TGA regulations for clinical trials and adverse event reporting.
• Proficient in Microsoft Word, Excel, PowerPoint.
• Proactive in solving problems and driving objectives.
• Clear communication and collaboration across study teams.

Responsibilities

• Coordinate clinical study programs in the region.
• Assess feasibility, logistics, budget, and timelines for studies.
• Identify investigators and manage CRO involvement as needed.
• Prepare Ethics and Governance submission documentation.
• Oversee device logistics and supplier coordination.
• Mentor CRAs and ensure timely data collection and SAE reporting.

Skills

Clinical monitoring

ICH GCP knowledge

Communication skills

Problem solving

Education

Bachelor’s degree in a scientific field

Tools

Microsoft Office

Job description

Abbott in Sydney is seeking an experienced Clinical Study Coordinator for a 12-month contract. The role focuses on coordinating designated regional clinical study programs, overseeing budgets and logistics, and ensuring compliance with ICH GCP and local regulations.

You will liaise with investigators, CROs, and Abbott stakeholders to deliver trials on time and within scope. The role requires strong monitoring experience, solid MS Office skills, and the ability to work across multiple sites.