Senior Global Clinical Study Manager

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $136.4k - $181.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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, budget, and inspection-readiness quality • Lead all aspects of assigned clinical studies • Lead global cross-functional study teams and oversee external partners • Act as escalation point for study-related issue resolution • Align study goals with clinical operations and corporate objectives • Develop global tools and standards, work instructions, and SOPs • Support onboarding and high-quality execution of external partner projects • Lead vendor management and collaborate with regional subject matter experts • Provide study progress updates to senior management • Lead study planning and management from feasibility through closeout • Manage study timelines, feasibility, site selection, startup, activation, and study plans • Ensure regulatory and ethics committee submission documents are available • Implement risk-based quality management processes and maintain study systems • Develop study-specific training and maintain training records • Create, maintain, and quality-control the Trial Master File • Forecast study drug supplies and coordinate delivery to sites • Support data cleaning timelines and Clinical Study Report planning • Monitor compliance with protocols, SOPs, ICH/GCP, study plans, and regulations • Manage quality metrics, inspection readiness, audits, inspections, risks, and corrective/preventive actions • Select and manage vendors and approve invoice payments • Manage study budgets, forecasts, accruals, resources, and contingency plans • Participate in process-improvement initiatives and share best practices

🎯 Requirements

• Bachelor’s degree in a scientific or healthcare discipline required, with exceptions possible for candidates with relevant clinical operations experience • 8 or more years of progressive experience in clinical research within biotech, pharma, or CRO industry • Proven project management experience in global clinical studies • Advanced knowledge of clinical operations methodologies • In-depth understanding of all aspects of clinical study processes • Ability to independently lead global clinical studies • MS Office proficiency • Project planning applications proficiency • Clinical Trial Management Systems (CTMS) proficiency • Ability to travel domestically and internationally, up to 20% • Oncology experience preferred • Higher degree preferred

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary Employee Stock Purchase Plan participation • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits • Reasonable accommodation for individuals with disabilities

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