Clinical Trial Manager in Melbourne

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.
• #J-18808-Ljbffr