Senior Global Clinical Study Manager

This is a fully remote position, open to applicants in Australia, +1 more country.

📋 Description

• Responsible for the global delivery of studies within established timelines and budgets, ensuring appropriate quality for inspection readiness.

• Oversee all facets of assigned clinical studies.

• Lead global cross-functional study teams, providing oversight of external partners and serving as the primary escalation point.

• Align study objectives with clinical operations and corporate goals.

• Manage relationships with external vendors.

• Collaborate with regional subject matter experts and organizational stakeholders.

• Provide regular updates on study progress to senior management.

• Direct study planning and management from feasibility through to closeout.

• Create, maintain, communicate, and monitor study timelines.

• Supervise trial feasibility, resource allocation, and site selection across regions.

• Ensure the availability of high-quality study documents for regulatory and ethics submissions.

• Manage study startup and site activation strategies.

• Develop, update, distribute, and implement study plans.

• Ensure study systems and tools are properly configured and operational.

• Implement risk-based quality management processes along with centralized monitoring analyses.

• Design and deliver study-specific training while maintaining training records.

• Create, maintain, and routinely quality check the Trial Master File.

• Anticipate study drug needs and coordinate the timely delivery of supplies to sites.

• Assist in maintaining data cleaning timelines in collaboration with Data Management and other stakeholders.

• Plan and execute the Clinical Study Report.

• Monitor adherence to protocols, SOPs, study plans, ICH/GCP, and relevant regulations.

• Manage quality metrics, inspection readiness, risks, corrective and preventive actions, audits, and inspections.

• Oversee study vendors, including invoices, budgets, accruals, forecasts, and resource utilization.

• Ensure studies are conducted within the approved time, quality, and cost parameters.

• Provide performance feedback on team members as necessary.

⛳️ Requirements

• Bachelor’s Degree in a scientific or healthcare field is required.

• A higher degree is preferred.

• Proficiency in MS Office.

• Experience with Project Planning Applications.

• Familiarity with Clinical Trial Management Systems.

• Demonstrated Project Management experience in Global Clinical Studies.

• Oncology experience is preferred.

• Advanced understanding of clinical operations methodologies.

• Comprehensive knowledge of all aspects of clinical study processes.

• Capability to independently lead global clinical studies.

• Required pivotal study management experience.

• At least 6 years of progressive experience in clinical research within the biotech, pharma, or CRO sectors.

• Travel may be necessary based on business requirements.

🏝️ Benefits

• Competitive compensation package with a performance-based annual bonus scheme.

• Company shares (including a generous welcome grant!).

• Opportunities for in-house and external learning and development.

• Comprehensive benefits program.

• A dynamic, collaborative, supportive, inclusive, and enjoyable team environment.