Role/Function Summary:

We are seeking an experienced Associate Project Manager (APM) or Project Manager (PM) 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 APM/PM 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.

Experience:

- Minimum 5 years of experience in clinical research, with at least 2–3 years of experience in a Clinical Project Management (APM/PM) 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 solid 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 popula

📌 (Associate) PM, Clinical Operations (Australia)
🏢 Sironax
📍 Australia