Job Description
Project Manager / Senior Project Manager - Clinical Research
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Location: Australia
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Employment: Permanent
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The Opportunity
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Our client is an established international clinical research organisation supporting biotechnology and pharmaceutical companies in the development of new therapies.
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As part of the continued development of its Australian clinical operations capability, the organisation is seeking an experienced Project Manager / Senior Project Manager to lead the delivery of clinical studies and serve as a key interface between sponsors and multidisciplinary study teams.
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This opportunity would suit an experienced clinical research professional who enjoys taking ownership of complex studies, working directly with sponsors and coordinating cross-functional teams in an international environment.
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The Role
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You will assume overall responsibility for assigned clinical studies, from study planning and start-up through execution and delivery.
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Working closely with sponsors, clinical operations, regulatory, data management, safety and other functional specialists, you will ensure studies progress against agreed scope, timelines, quality standards and financial objectives.
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The position combines clinical project leadership, sponsor management, operational oversight and commercial accountability.
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Key Responsibilities
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Lead the planning, implementation and delivery of assigned clinical studies.
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Act as a primary operational contact for sponsors and maintain effective communication throughout the study lifecycle.
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Establish study plans, timelines, milestones, resource requirements and project controls.
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Coordinate cross-functional study teams and ensure clarity of responsibilities, priorities and deliverables.
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Identify project risks early and develop appropriate mitigation and contingency strategies.
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Maintain oversight of project budgets, forecasts, scope and financial performance.
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Identify material changes to project scope and support the appropriate commercial change-control process.
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Oversee external vendors and specialist service providers required for study delivery.
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Guide site identification, evaluation, activation and ongoing study performance.
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Coordinate activities associated with ethics and regulatory submissions together with relevant specialist teams.
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Monitor enrolment and retention performance and develop corrective strategies where study recruitment falls behind plan.
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Maintain oversight of monitoring activities, site issues and protocol/GCP compliance.
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Coordinate with data management and drug-safety functions to ensure study objectives and timelines are achieved.
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Ensure clinical documentation and trial master-file activities meet applicable quality and regulatory requirements.
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Provide regular project updates, including risks, timelines, operational performance and financial status, to sponsors and internal leadership.
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Contribute to operational improvements and the continued development of project-management practices.
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Where appropriate, provide project and feasibility input during proposal development and sponsor discussions.
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What We Are Looking For
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You should bring a combination of clinical research knowledge and demonstrated project-management capability, ideally developed within a CRO, biotechnology, pharmaceutical or closely related clinical research setting.
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Key Requirements Include
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Degree in life sciences, clinical sciences or another relevant discipline; equivalent relevant professional experience may also be considered.
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Minimum 5 years' experience within clinical research.
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Previous responsibility for clinical study/project management, whether as a Project Manager, Associate Project Manager or equivalent.
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Experience managing clinical trials across different stages of clinical development.
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Strong Phase I and/or Phase II experience.
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Project-management experience within at least one relevant therapeutic area such as:
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Early Clinical Development
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Oncology
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CNS
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Immunology
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Good working knowledge of ICH-GCP and applicable clinical research regulations.
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Demonstrated ability to coordinate multidisciplinary study teams and manage competing priorities.
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Strong sponsor/client communication and stakeholder-management capability.
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Experience managing study budgets, timelines, risks and operational deliverables.
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Previous CRO experience would be advantageous but is not essential.
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📌 Project Manager / Senior Project Manager - Clinical Research (New South Wales)
🏢 NexusHire Solutions
📍 New South Wales