Senior Global Clinical Study Manager

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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

• Own global study delivery within agreed timelines, budget, quality, and inspection-readiness requirements for Clinical SuperHighway partnership studies • Lead all aspects of assigned clinical studies from feasibility through closeout • Lead global cross-functional study teams and oversee external partners and vendors • Act as escalation point for study-related issues and keep senior management informed of progress, risks, and challenges • Plan and manage study timelines, feasibility, site selection, startup, site activation, submissions, and closeout activities • Ensure study plans, systems, tools, training, and Trial Master Files are created, maintained, QC’d, and implemented appropriately • Implement risk-based quality management processes and monitor study compliance with protocols, SOPs, ICH/GCP, and regulations • Prepare teams for quality assurance audits and inspections and ensure ongoing inspection readiness • Coordinate supplies forecasting and delivery, data cleaning timelines, and Clinical Study Report planning • Manage study vendors, budgets, invoices, accruals, forecasts, and resource needs • Contribute to process improvements and develop or optimize work instructions and SOPs

🎯 Requirements

• 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 • 8 or more years of progressive clinical research experience within biotech, pharma, or CRO industry • Bachelor’s degree in a scientific or healthcare discipline required; exceptions may be made for candidates with relevant clinical operations experience • Higher degree preferred • Proficiency with MS Office, project planning applications, and Clinical Trial Management Systems (CTMS)

🏖️ Benefits

• Annual bonus plan eligibility for Non-Commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness program