Global Clinical Project Lead (12-Month Contract) - Sydney

Abbott; Sydney; Vor Ort; AUD 120.000 - 180.000; Vollzeit

Zusammenfassung

Abbott in Sydney is seeking a Senior Clinical Study Coordinator on a 12-month contract. The role manages regional clinical study programs, from feasibility and budgeting to investigator selection and site monitoring, ensuring regulatory compliance and data integrity.

The successful candidate will mentor CRAs, coordinate ethics submissions, and oversee device logistics while liaising with Abbott HQ and country offices to meet project timelines and quality standards.

Qualifikationen

• 5+ years’ experience in medical device industry with monitoring exposure.
• Knowledge of ICH GCP guidelines and implementation.
• Familiarity with TGA regulations for clinical trials and adverse event reporting.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).

Aufgaben

• Coordinate designated clinical study programs regionally.
• Assess feasibility, logistics, timeframe and budget of studies.
• Review study design including protocol and CRF.
• Identify and select investigators to conduct trials.
• Coordinate ethics and governance submissions.
• Oversee device logistics and accountability.
• Negotiate study budgets and contracts with sites.
• Mentor CRAs and conduct site visits.
• Ensure compliance with ICH GCP and ISO 14155.
• Prepare monthly tracking reports for project management.

Kenntnisse

Medical devices

Clinical monitoring

GCP knowledge

Regulatory knowledge

Tools

Microsoft Office

Jobbeschreibung

Abbott in Sydney is seeking a Senior Clinical Study Coordinator on a 12-month contract. The role manages regional clinical study programs, from feasibility and budgeting to investigator selection and site monitoring, ensuring regulatory compliance and data integrity.

The successful candidate will mentor CRAs, coordinate ethics submissions, and oversee device logistics while liaising with Abbott HQ and country offices to meet project timelines and quality standards.