Project Manager / Senior Project Manager – Clinical Research

NexusHire Solutions; Sydney; On-site; AUD 120,000 - 180,000; Full time

Job summary

NexusHire Solutions seeks an experienced Project Manager / Senior Project Manager to lead clinical studies in Australia. You will own planning from startup to delivery, coordinating sponsors, regulatory teams, data management, and safety to meet scope, timelines and budgets.

The role requires a strong clinical research background, with 5+ years of achievement in PM roles within CRO/biotech/pharma settings, and proven stakeholder management across cross-functional teams.

Qualifications

• Clinical research knowledge and proven project-management capability are required.
• Minimum 5 years' experience in clinical research.
• Experience managing clinical study/projects (PM or equivalent).
• Experience across different stages of clinical development, including Phase I/II.
• Strong sponsor/client communication and stakeholder-management capability.
• PM experience in Early Clinical Development, Oncology, CNS, or Immunology.

Responsibilities

• Lead planning, implementation and delivery of assigned clinical studies.
• Act as primary operational contact for sponsors and maintain communication throughout the study lifecycle.
• Establish study plans, timelines, milestones, resource requirements and controls.
• Coordinate cross-functional study teams and ensure responsibilities and deliverables.
• Identify project risks early and develop mitigation and contingency strategies.
• Oversee budgets, forecasts, scope and financial performance.
• Manage changes to project scope and support change-control processes.
• Oversee external vendors and service providers for study delivery.
• Guide site identification, activation and ongoing performance.
• Coordinate ethics and regulatory submissions with relevant teams.
• Monitor enrolment and retention and adjust strategies as needed.
• Oversee monitoring activities, site issues and protocol/GCP compliance.
• Coordinate with data management and safety functions to meet objectives.
• Ensure trial master-file activities meet quality and regulatory requirements.
• Provide regular project updates to sponsors and leadership.
• Contribute to process improvements in project-management practices.
• Provide input during proposal development and sponsor discussions.

Skills

Project management

Clinical research knowledge

Sponsor communication

Stakeholder management

Cross-functional leadership

ICH-GCP knowledge

Education

Life sciences degree

Job description

Project Manager / Senior Project Manager - Clinical Research

Location: Australia

Employment: Permanent

The Opportunity

Our client is an established international clinical research organisation supporting biotechnology and pharmaceutical companies in the development of new therapies.

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.

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.

The Role

You will assume overall responsibility for assigned clinical studies, from study planning and start-up through execution and delivery.

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.

The position combines clinical project leadership, sponsor management, operational oversight and commercial accountability.

Key Responsibilities

• Lead the planning, implementation and delivery of assigned clinical studies.
• Act as a primary operational contact for sponsors and maintain effective communication throughout the study lifecycle.
• Establish study plans, timelines, milestones, resource requirements and project controls.
• Coordinate cross-functional study teams and ensure clarity of responsibilities, priorities and deliverables.
• Identify project risks early and develop appropriate mitigation and contingency strategies.
• Maintain oversight of project budgets, forecasts, scope and financial performance.
• Identify material changes to project scope and support the appropriate commercial change-control process.
• Oversee external vendors and specialist service providers required for study delivery.
• Guide site identification, evaluation, activation and ongoing study performance.
• Coordinate activities associated with ethics and regulatory submissions together with relevant specialist teams.
• Monitor enrolment and retention performance and develop corrective strategies where study recruitment falls behind plan.
• Maintain oversight of monitoring activities, site issues and protocol/GCP compliance.
• Coordinate with data management and drug-safety functions to ensure study objectives and timelines are achieved.
• Ensure clinical documentation and trial master-file activities meet applicable quality and regulatory requirements.
• Provide regular project updates, including risks, timelines, operational performance and financial status, to sponsors and internal leadership.
• Contribute to operational improvements and the continued development of project-management practices.
• Where appropriate, provide project and feasibility input during proposal development and sponsor discussions.

What We Are Looking For

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 environment.

Key Requirements Include

• Degree in life sciences, clinical sciences or another relevant discipline; equivalent relevant professional experience may also be considered.
• Minimum 5 years' experience within clinical research.
• Previous responsibility for clinical study/project management, whether as a Project Manager, Associate Project Manager or equivalent.
• Experience managing clinical trials across different stages of clinical development.
• Strong Phase I and/or Phase II experience.
• Project-management experience within at least one relevant therapeutic area such as:

• Early Clinical Development
• Oncology
• CNS
• Immunology

• Good working knowledge of ICH-GCP and applicable clinical research regulations.
• Demonstrated ability to coordinate multidisciplinary study teams and manage competing priorities.
• Strong sponsor/client communication and stakeholder-management capability.
• Experience managing study budgets, timelines, risks and operational deliverables.
• Previous CRO experience would be advantageous but is not essential.