Remote Australia-Based Study Start-Up Specialist

Avance Clinical Pty; Sydney; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Stimulating work

Project diversity

Progress opportunities

Competitive salary

Birthday day off

Job summary

Avance Clinical Pty is seeking an experienced Study Start-Up (SSU) Specialist I based in Australia, with remote work option within Australia. You will drive site activation, budgets, regulatory submissions, and ethics committee interactions, reporting to the Project Manager and liaising with sponsors.

Ideal candidates have CRO/Pharma SSU experience, ICH-GCP knowledge, and strong communication skills. Travel to sites may be required; supportive team culture is emphasized.

Qualifications

• SSU experience in CRO/Pharma or clinical trials preferred.
• Working knowledge of ICH GCP and regulatory requirements.
• Ability to maintain client confidentiality and data integrity.
• Excellent written and oral communication with stakeholders.

Responsibilities

• Develop and manage study start-up timelines and report progress.
• Act as primary contact with Investigator sites, Sponsor, and Avance PM/Lead CRA.
• Report status/metrics at sponsor meetings and communicate outcomes.
• Draft country- and site-level budgets; negotiate CTAs/CTRAs as needed.
• Manage EC/IRB submissions and local language materials per regulations.
• Prepare regulatory submissions and document maintenance.
• Oversee clinical trial public registry submissions and upkeep.
• Coordinate Investigational Product import licenses with Regulatory Affairs.
• Collect essential documents for site activation in collaboration with Clinical Ops.
• Participate in audits and respond to observations as required.
• Provide guidance and mentoring to junior SSU staff.
• Perform other duties as directed by Line Management.

Skills

SSU experience

ICH GCP knowledge

Confidentiality ethics

Written communication

Verbal communication

Problem solving

Privacy legislation

Work under pressure

Team player

Travel readiness

Education

Bachelor’s degree in life sciences, pharmacy, nursing, or equivalent field

Job description

Avance Clinical Pty is seeking an experienced Study Start-Up (SSU) Specialist I based in Australia, with remote work option within Australia. You will drive site activation, budgets, regulatory submissions, and ethics committee interactions, reporting to the Project Manager and liaising with sponsors.

Ideal candidates have CRO/Pharma SSU experience, ICH-GCP knowledge, and strong communication skills. Travel to sites may be required; supportive team culture is emphasized.