Senior Global Clinical Study Manager

🔥 9 hours 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

• Own end-to-end global operational delivery of one or more clinical studies from study start-up through close-out • Align cross-functional stakeholders and execute global study strategy against timelines, quality, and budget • Lead global clinical operations teams and serve as escalation point for regional issues • Ensure alignment of global deliverables with study goals • Develop global tools, work instructions, and SOPs • Provide hands-on leadership, oversight, proactive risk management, and decision-making for global study teams • Lead study execution, including start-up strategy, enrollment acceleration, site activation, data flow, and query resolution • Provide oversight and direction to regional clinical study managers • Coordinate Clinical Operations, Medical, Regulatory, Biometrics, Supply, and other functions • Plan and manage studies from feasibility through closeout • Manage study start-up and recruitment timelines and track progress • Drive trial feasibility, country allocation, and site selection • Ensure timely availability and submission of study documents to regulatory authorities and ECs/IRBs • Maintain accurate study systems and tools • Collaborate with CRAs, review and sign off monitoring reports • Create, maintain, and QC country- and site-level Trial Master Files • Provide input on regional drug inventories, labels, regulatory approvals, and comparator reimbursement • Manage regional trial data collection, data entry, and query resolution • Support Clinical Study Report planning and execution • Monitor compliance with protocol, SOPs, ICH/GCP, and regulations • Ensure inspection readiness and prepare sites for audits and inspections • Manage audit and inspection responses and share learnings and best practices • Improve efficiency and quality of assigned studies • Plan, track, and forecast global study budgets • Allocate resources across regions and manage regional budgets • Manage cost versus performance trade-offs and study vendors • Coordinate investigator fees, site payments, and patient travel reimbursement • Identify resource needs, contingency plans, and resource utilization • Represent study leadership in cross-functional reviews • Communicate study status, risks, trade-offs, and mitigation plans • Mentor junior team members and support onboarding

🎯 Requirements

• Over 5 years’ project management in clinical trials within the biotech, pharmaceutical sector, CRO industry or relevant field • Proven experience in clinical research including relevant experience as team lead in clinical functions • Bachelor’s Degree in a scientific or healthcare discipline required • Higher Degree preferred • MS Office • Project Planning Applications • Travel might be required as per business need

🏖️ Benefits

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