Senior Clinical Operations Lead — Rare Diseases (Australia)

Sironax; Australia; On-site; AUD 180,000 - 260,000; Full time

Job summary

Sironax is seeking an experienced Senior PM or AD to lead operational execution of a clinical trial across Australian sites, ensuring timelines and budget while adhering to ICH-GCP, TGA regulations, and sponsor SOPs. The role addresses rare disease complexities, including limited site networks and collaboration with KOLs.

The candidate will lead cross-functional teams, activate sites, manage vendors, oversee regulatory submissions, TMF, safety, and trial close-out across Australia, with strong

Qualifications

• Minimum 8 years in clinical research with 3–4 years in Clinical Project Management.
• Experience in rare diseases, autoinflammatory disorders, haematology or rheumatology preferred.
• Proven track record managing full lifecycle of clinical trials in Australia with TGA/HREC knowledge.

Responsibilities

• Lead cross-functional study team (CRO, CRA, data management, biostatistics, labs, vendors) to hit milestones.
• Identify and activate specialised sites and engage KOLs to enable patient recruitment.
• Oversee site startup, monitoring activities, and study conduct with protocol adherence.
• Manage external vendors to meet KPIs and budgets; review invoices.
• Maintain TMF readiness and safety reporting with Drug Safety.
• Coordinate regulatory submissions to HREC and TGA and ensure compliance.

Skills

Leadership & cross-functional collab

ICH-GCP & regulatory compliance

Budgeting & vendor management

Study start-up & regulatory filings

Stakeholder engagement (KOLs, sites)

RBM / risk-based monitoring

Education

Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field

Advanced degree (MSc, MBA, or PhD) desirable

Job description

Sironax is seeking an experienced Senior PM or AD to lead operational execution of a clinical trial across Australian sites, ensuring timelines and budget while adhering to ICH-GCP, TGA regulations, and sponsor SOPs. The role addresses rare disease complexities, including limited site networks and collaboration with KOLs.

The candidate will lead cross-functional teams, activate sites, manage vendors, oversee regulatory submissions, TMF, safety, and trial close-out across Australia, with strong