(Associate) PM, Clinical Operations

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).

• 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.

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

• Full legal working rights in Australia are required.

• 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 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.

• Proficient in Microsoft Office Suite (Project, PowerPoint, Excel, Word); advanced Excel skills for tracking metrics and budgets are required.
• Experience with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems (e.g., Rave, Veeva), and eTMF systems (e.g., Veeva Vault).
• Strong leadership and communication skills, with the ability to influence cross-functional teams, investigators, and KOLs in a rare disease setting.
• Exceptional organisational and problem-solving abilities, with a demonstrated capacity to manage complexity and ambiguity in a fast-paced environment.
• High level of financial acumen regarding study budgets, forecasting, and invoice reconciliation.
• Ability to work independently while maintaining strong alignment with the sponsor’s Clinical Operations team.
• Strong understanding of ICH-GCP, TGA regulations, and regulatory guidelines applicable to investigational products and clinical trial conduct in rare diseases.

• Valid driver’s licence and willingness to travel domestically to investigational sites across Australia.
• Ability to undertake regular onsite monitoring visits, with expected travel of approximately 40–60% depending on site location and study needs.

This job description outlines the key responsibilities and requirements of the role and is not intended to be an exhaustive list of all duties. Responsibilities may be adjusted in line with study needs and organisational priorities.