Clinical Trial Manager

Linical; Melbourne; On-site; AUD 120,000 - 170,000; Full time

Job summary

Linical in Melbourne is seeking an experienced Clinical Trial Manager to oversee delivery of clinical trials across therapeutic areas. You will ensure studies meet ICH-GCP guidelines and sponsor requirements while managing timelines, budgets, and cross-functional teams.

The role requires strong leadership, global trial management experience, and excellent communication with CRAs, sites, and clients. You will drive operational excellence and contribute to study budgets and proposals as needed.

Qualifications

• Degree in Life Sciences, Nursing or related discipline, or equivalent industry experience.
• Minimum of three years' experience in Clinical Trial Management.
• Strong understanding of clinical trial processes, regulations, and ICH-GCP requirements.

Responsibilities

• Manage the clinical operational aspects of assigned studies from start-up through close-out.
• Develop and implement study activation plans and oversee site start-up activities.
• Coordinate site identification, feasibility, selection, activation, and recruitment.
• Oversee regulatory and ethics submissions and ensure timely collection of essential documents.
• Manage clinical study timelines, milestones, and deliverables, proactively identifying and mitigating risks.
• Serve as the primary point of contact for CRAs, study teams, and key stakeholders.
• Develop monitoring plans, study tools, and training materials.
• Provide leadership, guidance, and oversight to CRAs and study team members.
• Monitor study performance, data quality, patient enrollment, and site compliance.
• Conduct remote review of clinical data and collaborate with sites and monitoring teams to resolve issues.

Skills

Project management

Leadership

Stakeholder management

Communication

Prioritization

Clinical trial systems

Microsoft Office

ICH-GCP knowledge

Global/multi-site trials

Education

Life Sciences/Nursing or related discipline

Tools

Microsoft Office

Clinical trial systems

Project management tools

Job description

We are looking for an experienced and driven Clinical Trial Manager to oversee and manage the successful delivery of clinical trials across a variety of therapeutic areas. This role is ideal for a clinical research professional with strong leadership skills, a passion for operational excellence, and extensive experience managing study timelines, budgets, and cross-functional teams.

As a Clinical Trial Manager, you will play a pivotal role in ensuring studies are conducted in compliance with ICH-GCP guidelines, sponsor requirements, company SOPs, and applicable regulatory standards, while delivering high-quality results for our clients and patients.

Key Responsibilities:

• Manage the clinical operational aspects of assigned studies from start-up through close-out.
• Develop and implement study activation plans and oversee site start-up activities.
• Coordinate site identification, feasibility, selection, activation, and recruitment.
• Oversee regulatory and ethics submissions and ensure timely collection of essential documents.
• Manage clinical study timelines, milestones, and deliverables, proactively identifying and mitigating risks.
• Serve as the primary point of contact for CRAs, study teams, and key stakeholders.
• Develop monitoring plans, study tools, and training materials.
• Provide leadership, guidance, and oversight to CRAs and study team members.
• Monitor study performance, data quality, patient enrollment, and site compliance.
• Conduct remote review of clinical data and collaborate with sites and monitoring teams to resolve issues.
• Review and approve monitoring reports, follow-up letters, expense reports, and timesheets.
• Ensure Trial Master File (TMF) quality and compliance requirements are maintained.
• Manage vendor relationships, contracts, budgets, and performance where applicable.
• Support study budget management, expense tracking, and financial forecasting activities.
• Participate in client meetings, investigator meetings, project reviews, and study team discussions.
• Contribute to business development activities, including proposal development and bid defence meetings when required.
• Ensure all studies are conducted in accordance with protocol requirements, ICH-GCP, local regulations, and company procedures.
• Degree in Life Sciences, Nursing, or a related discipline, or equivalent industry experience.
• Minimum of three years' experience in Clinical Trial Management.
• Strong understanding of clinical trial processes, regulations, and ICH-GCP requirements.
• Experience managing global or multi-site clinical studies.
• Excellent project management, planning, and organizational skills.
• Strong leadership and team management capabilities.
• Outstanding communication, stakeholder management, and client relationship skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with clinical trial systems, project management tools, and Microsoft Office applications.

Preferred Experience:

• Previous experience working as a Clinical Research Associate (CRA).
• Vendor management and budget oversight experience.
• Experience supporting global clinical trials across multiple regions.