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 solid 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.

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📌 Clinical Trial Manager (Melbourne)
🏢 Linical
📍 Melbourne