Senior PM/AD, Clinical Operations - (Australia)

Sironax; Victoria; 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

Role/Function Summary:

We are seeking an experienced Senior PM or AD to lead the operational execution of a clinical trial across Australian sites. This role is responsible for the end-to-end management of the study, serving as the primary operational liaison between the sponsor, CRO, sites, and vendors. The Senior PM or AD will ensure delivery within timelines and budget, with strict adherence to ICH-GCP, TGA regulations, and sponsor SOPs, while addressing the unique complexities associated with a rare disease study, including limited site networks, specialised patient identification, and close collaboration with key opinion leaders (KOLs).

Responsibilities and Duties:

• Study Leadership & Strategy: Lead the cross-functional study team (CRO, CRA team, data management, biostatistics, central labs, and specialty vendors) to align on milestones, deliverables, and strategic execution plans tailored to a rare disease population.
• Site Network & KOL Engagement: Identify, qualify, and support the activation of specialised sites with expertise in haematology, rheumatology, or autoinflammatory diseases. Build strong relationships with key opinion leaders (KOLs) and site investigators to facilitate patient identification and recruitment.
• Patient Recruitment & Retention: Develop and execute a patient recruitment and retention strategy appropriate for a rare disease, leveraging patient advocacy groups, referral networks, and targeted recruitment campaigns. Proactively monitor and mitigate enrollment risks.
• Operational Management: Oversee all operational aspects including site startup (regulatory submissions, SIVs), clinical monitoring activities, and study conduct. Ensure strict compliance with the Clinical Monitoring Plan and protocol requirements, particularly around complex diagnostic criteria and safety assessments.
• Vendor Oversight: Manage external vendors (CRO, central laboratory, IXRS, specialty drug distribution, and diagnostic vendors) to ensure KPIs, SLAs, and contractual obligations are met. Review vendor invoices and scopes of work to maintain budget control.
• Budget & Timeline Management: Track study budget, forecasts, and accruals. Maintain the master study timeline and drive achievement of key milestones (First Patient In, Last Patient Last Visit, Database Lock), accounting for the extended timelines often associated with rare disease recruitment.
• Data Quality & Compliance: Oversee review of data listings, monitoring reports, and protocol deviations to ensure data integrity, patient safety, and inspection readiness. Collaborate with the CRO to resolve site performance issues and data queries.
• Trial Master File (TMF) Management: Ensure TMF is maintained in a state of inspection readiness by overseeing TMF operations and conducting regular quality reviews.
• Safety & Pharmacovigilance: Work closely with Drug Safety to ensure timely and accurate reporting of Serious Adverse Events (SAEs) and management of safety signals, particularly those relevant to autoinflammatory conditions.
• Regulatory & Ethics: Coordinate the preparation and submission of study documents to Australian Ethics Committees (HREC) and the Therapeutic Goods Administration (TGA), ensuring compliance with all local regulatory requirements.
• Communication: Facilitate study team meetings, prepare executive-level status reports, and serve as the primary operational point of contact for internal stakeholders, CRO, and sites.
• Close-out: Lead study close-out activities, including site close-out visits, final data validation, final TMF archival, and financial reconciliation with sites and vendors.

Educational Requirements

• A university degree in Life Sciences, Pharmacy, Nursing, or a related field is required. Advanced degree (MSc, MBA, or PhD) is highly desirable.

Other Requirements

• Full legal working rights in Australia are required.

Experience

• Minimum 8 years of experience in clinical research, with at least 3-4 years of experience in a Clinical Project Management role within a Sponsor, CRO, or pharmaceutical environment.
• Experience in rare diseases, autoinflammatory disorders, haematology, or rheumatology is highly preferred. Prior exposure to complex genetic/inflammatory conditions is a strong advantage.
• Demonstrated experience managing the full lifecycle of a clinical trial in Australia, from study startup to close-out, with a strong understanding of TGA and HREC requirements.
• Prior experience as a Senior CRA or Lead CRA is highly advantageous, providing a strong foundation in site management, monitoring, and investigator engagement.
• Proven track record of successful vendor management (CROs, central labs, specialty drug vendors) and budget/financial oversight.
• Experience with risk-based monitoring (RBM) strategies, patient recruitment in rare populations, and collaborative engagement with patient advocacy groups.

About Sironax

Sironax is a global clinical-stage biotechnology company focused on developing innovative therapies for neurodegenerative, inflammatory, immunologic, and rare diseases. Driven by scientific excellence and a patient-centered mission, Sironax is expanding its global presence to transform treatment paradigms and improve outcomes for patients worldwide.

Equal Opportunity Employer

Sironax is an equal opportunity employer committed to diversity, equity, and inclusion. We welcome applicants from all backgrounds and are dedicated to creating a work environment where everyone feels valued and empowered.