Australia Clinical Start-Up Specialist

AbbVie; Sydney; On-site; AUD 90,000 - 120,000; Full time

Job summary

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

You’ll bring clinical research, study start-up, site activation or regulatory submissions experience, solve problems, manage competing priorities

Qualifications

• Bachelor's Degree in health care or scientific field or equivalent years of experience.
• 1–2 years of clinical research experience; 1+ years in study start-up management for the region.
• Experience working with remote/virtual teams.
• Strong analytical and critical thinking skills; ability to evaluate complex issues.
• Strong interpersonal skills; ability to communicate with clarity and adaptability.
• Experience in start-up execution and managing multiple priorities in a fast-paced environment.
• Working knowledge of ICH and GCP guidelines and regulatory environment.

Responsibilities

• Coordinate ethics submissions and essential documentation for site activation.
• Manage site activation plans, risks, and mitigation with cross-functional leads.
• Identify issues impacting delivery and propose solutions.
• Participate in regional start-up calls and collect essential documents with ALCOA checks.
• Coordinate ICF customization, patient materials and safety reporting with Regulatory and CTS.
• Collaborate with contract managers and CRAs to assure timely site activation.
• Review site/IRB/EC comments on ICFs and route for approvals; trigger IP shipments.

Skills

Clinical research experience

Study start-up management

Remote/virtual teams

Analytical thinking

Interpersonal skills

Regulatory knowledge (ICH/GCP)

Education

Bachelor's Degree in health care or scientific field

Tools

Vault SSU

IXRS

ALCOA principles

Job description

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

You’ll bring clinical research, study start-up, site activation or regulatory submissions experience, solve problems, manage competing priorities