Senior Global Clinical Study Manager

BeOne Medicines

. Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality .

Posted 11/10/2026full-timeRemote • Australia, New ZealandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading global clinical studies, ensuring compliance with protocols, ICH/GCP, and regulatory requirements while managing timelines, budgets, and quality metrics. Proficient in vendor management and cross-functional collaboration to achieve study objectives.

Highest-signal resume keywords

Project Management ExperienceClinical Trial Management SystemsOncology ExperienceClinical Operations MethodologiesPivotal Study Management Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProcessesStudy PlanningRisk-Based Quality ManagementData CleaningTrial Master File ManagementBudget ManagementStudy Timeline TrackingSite SelectionRegulatory SubmissionsInspection Readiness

Soft Skills

LeadershipCollaborationCommunicationProblem-SolvingPerformance Feedback

Tools & Technologies

MS OfficeProject Planning ApplicationsClinical Trial Management Systems

Industry Keywords

Clinical ResearchBiotechPharmaCROOncology

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
Lead all aspects of assigned clinical studies
Lead global cross-functional study teams, including oversight of external partners, and act as point of escalation
Align study goals with clinical operations and corporate goals and objectives
Lead external vendor management
Collaborate with regional subject matter experts and organizational stakeholders
Provide regular study progress updates to senior management
Lead study planning and management from feasibility through closeout
Generate, maintain, communicate, and track study timelines
Oversee trial feasibility, allocation, and site selection across regions
Ensure high-quality study documents are available for regulatory and ethics submissions
Oversee study startup and site activation plans
Create, update, distribute, and implement study plans
Ensure study systems and tools are configured and functioning properly
Implement risk-based quality management processes and centralized monitoring analyses
Develop and implement study-specific training and maintain training records
Create, maintain, and regularly QC the Trial Master File
Forecast study drug and coordinate timely delivery of supplies to sites
Support data cleaning timelines with Data Management and other stakeholders
Plan and execute the Clinical Study Report
Monitor compliance with protocols, SOPs, study plans, ICH/GCP, and applicable regulations
Manage quality metrics, inspection readiness, risks, corrective and preventive actions, audits, and inspections
Manage study vendors, invoices, budgets, accruals, forecasts, and resource utilization
Ensure studies are executed within approved time, quality, and cost parameters
Provide performance feedback on team members as required

Requirements

What you’ll need

Bachelor’s Degree in a scientific or healthcare discipline required
Higher Degree preferred
MS Office
Project Planning Applications
Clinical Trial Management Systems
Proven Project Management experience in Global Clinical Studies
Oncology experience preferred
Advanced knowledge of clinical operations methodologies
In-depth understanding of all aspects of clinical study processes
Ability to independently lead global clinical studies
Pivotal study management experience required
6 or more years of progressive experience in clinical research within biotech, pharma, or CRO industry
Travel might be required as per business need

Benefits

Comp & perks

Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
In-house and external learning and development opportunities
Fantastic benefits program
Dynamic, collaborative, supportive, inclusive, and fun team environment