Clinical Project Manager - Oncology
Viridian Financial Group
Clinical Project Manager – Oncology
Description
Overview
- ASX-listed oncology drug development company advancing multiple clinical programs including in Phase 3
- Full-time Sydney-based position (remote/hybrid) with competitive remuneration package
- Manage Racura Oncology’s lung cancer clinical programme, including sponsor and investigator-initiated trials
About Racura Oncology
Racura Oncology (ASX: RAC) is a Phase 3 clinical-stage biopharmaceutical company with a mission to silence cancer. Racura is advancing a proprietary formulation of (E,E)-bisantrene (RC220) to address the high unmet needs of patients across multiple oncology indications, with a Phase 3 clinical program in acute myeloid leukaemia (AML), a Phase 1a/b program in mutant epidermal growth factor receptor non-small cell lung cancer (EGFRm NSCLC), and a Phase 1a/b program in combination with the anthracycline doxorubicin, where we aim to deliver both cardioprotection and enhanced anticancer activity for solid tumour patients.
About the Role
As the company continues to grow and expand its clinical programmes, we are seeking an experienced Clinical Project Manager to be responsible for clinical trial execution and life cycle management across our clinical operations. This role is suited to someone who thrives in fast moving, science-driven environments, is comfortable managing internal and external stakeholders and who wants their efforts to directly contribute to advancing a new therapeutic for cancer patients in Australia and beyond.
This is a full-time, Sydney-based, hybrid position reporting to Racura’s Principal Scientist. You will be responsible for end-to-end operational oversight of our lung cancer clinical trial. You will liaise and work with clinical experts in oncology and related disciplines, including close collaboration with Racura’s preclinical, medical and manufacturing teams, advisors, external CROs and trial site staff.
Key Responsibilities
- Provide input into the end-to-end management of assigned clinical trials in accordance with ICH-GCP, relevant regulations and laws and company SOPs
- Manage CROs, external vendors and other stakeholders to ensure delivery of study start-up and ongoing trial activities to agreed timelines, budget, and quality standards
- Review and/or contribute to regulatory submissions and responses
- Liaise with scientific and commercial team members to ensure all relevant Racura Oncology employees are fully aware of clinical project progress.
- Develop and maintain detailed study start-up timelines, including critical path milestones to achieve First Patient First Visit (FPFV)
- Identify, assess and proactively mitigate study start-up risks, including site readiness, contracting delays, and operational challenges
- Establish and maintain effective vendor oversight, including regular communication, tracking of deliverables and issue escalation
- Review key CRO deliverables (e.g., start-up plans, monitoring plans, timelines) to ensure alignment with study objectives and company expectations
- Undertake tasks delegated by senior team members to assist other company projects
Essential for the Role
- Minimum 3 years’ experience as a clinical project manager
- Experience across early- and late-stage clinical trials
- Strong working knowledge of Good Clinical Practice (GCP)
- Operational and direct managerial experience in the planning, executing and reporting of clinical studies with experience interacting with senior stakeholders.
- Proven flexibility, collaborative skills and adaptability in a remote working environment
- Eagerness to drive timely milestones and outcomes
- Willingness to “roll up your sleeves” and do what is required to progress projects
- Excellent time management and prioritisation skills
- Ability to work autonomously
- Ability and willingness to travel
- Integrity and high ethical standards
- Full Australian work rights
Desirable for the Role
- Oncology experience
- Prior exposure to multi-national regulatory submissions
- Experience in small to mid-size sponsor environments
- Experience leading or supporting global, multi-centre clinical trials (Phase 2 preferred)
- Knowledge of pharmacokinetics
Remuneration Package
$125,000 – $140,000 base + 12% super + up to 20% performance cash bonus + equity in Racura valued at 50% base.
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