Senior Global Clinical Study Manager

🔥 37 minutes ago

🌐 Australia, New Zealand – Remote

🇦🇺 Australia – Remote 🇳🇿 New Zealand – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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

• 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

• 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

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