Australia Country Study Start-Up Specialist

AbbVie; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

AbbVie Australia is seeking a proactive Country Study Start Up Specialist to own the critical activities that move clinical studies from planning through to site activation in Australia. You will coordinate ethics submissions, essential documentation, informed consent materials and activation requirements, partnering with Clinical Operations, Regulatory Affairs, Contracts and global teams.

You'll navigate regulatory timelines, ensure quality standards, and help bring new medicines closer to

Qualifications

• Bachelor's degree in health care or scientific field (preferred) and relevant study start-up experience.
• 1–2 years of clinical research experience and regional study start-up exposure.
• Experience working with remote/virtual teams and global collaboration.
• Strong analytical and critical thinking abilities; capable of evaluating complex issues.

Responsibilities

• Coordinate ethics submissions and local regulatory documents for Australia.
• Prepare informed consent materials and essential study start-up documentation.
• Collaborate with Clinical Operations, Regulatory Affairs, Contracts, CRA teams, and regional/global SSU groups.
• Monitor timelines, risk factors, and escalation paths to ensure timely site activation.
• Support IP release, site activation tracking, and maintenance of study start-up metrics.

Skills

Clinical research

Study start-up

Remote teamwork

Critical thinking

Interpersonal Skills

Education

Bachelor's Degree in health care or scientific field

Job description

AbbVie Australia is seeking a proactive Country Study Start Up Specialist to own the critical activities that move clinical studies from planning through to site activation in Australia. You will coordinate ethics submissions, essential documentation, informed consent materials and activation requirements, partnering with Clinical Operations, Regulatory Affairs, Contracts and global teams.

You'll navigate regulatory timelines, ensure quality standards, and help bring new medicines closer to