Senior Global Clinical Study Manager

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $136.4k - $181.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

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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 • Act as point of escalation for resolution of study-related issues • Ensure alignment of study goals with clinical operations and corporate goals and objectives • Contribute to development of global tools and standards; lead development of work instructions and SOPs • Lead global cross-functional study teams and external vendor management • Collaborate with regional subject matter experts and organizational stakeholders • Provide regular study progress updates to senior management • Lead planning and management of clinical studies from feasibility through closeout • Manage study timelines, feasibility, trial allocation, site selection, startup, site activation, study plans, systems, training, TMF, data cleaning, supplies, and Clinical Study Reports • Monitor compliance with protocols, SOPs, study plans, ICH/GCP, and applicable regulations • Manage quality metrics, inspection readiness, audits, inspections, issues, CAPAs, risks, and mitigation plans • Select and manage study vendors and approve invoice payments • Manage study budgets, accruals, forecasts, and resource needs • Mentor junior team members

🎯 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 • Able to independently lead global clinical studies • 7+ or more years of progressive experience in clinical research within biotech, pharma or CRO industry • MS Office, Project Planning Applications, Clinical Trial Management Systems • Bachelor’s Degree in a scientific or healthcare discipline required • Travel might be required as per business need

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for 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