Global Clinical Study Manager

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $118.6k - $158.6k / year

⏰ Full Time

🟡 Mid-level

🟠 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, quality, and inspection-readiness requirements • Lead all aspects of assigned clinical studies • Lead global cross-functional study teams and oversee external partners • Act as escalation point for study-related issues • Align study goals with clinical operations and corporate objectives • Manage external vendors and study delivery partners • Build relationships with regional subject matter experts and support local study objectives • Collaborate with stakeholders and provide study-progress updates to senior management • Represent study teams at internal meetings and lead Clinical Study Team meetings • Lead study planning and management from feasibility through closeout • Generate, maintain, and communicate study timelines and track progress • Oversee trial feasibility, allocation, and site selection across regions • Ensure study documents support regulatory authority and EC/IRB submissions • Oversee study start-up and site activation plans • Create, update, distribute, and implement study plans • Ensure study systems and tools are set up and functioning properly • Implement risk-based quality management processes • 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 supply delivery to sites • Support data cleaning timelines with Data Management and other stakeholders • Plan and execute Clinical Study Reports with Medical Writing and study team members • Monitor compliance with protocols, SOPs, study plans, ICH/GCP, and applicable regulations • Review and manage quality-related metrics • Maintain inspection readiness throughout the study lifecycle • Identify study issues and ensure corrective and preventive actions are implemented • Communicate risks and challenges and implement mitigation plans • Prepare teams for quality assurance audits and inspections • Share cross-team, site learnings, and best practices • Lead improvements to enhance study efficiency and quality • Contribute to work instructions and SOP development and review • Select and manage study vendors and approve invoice payments • Manage study budgets, change control, closure budgets, accruals, and forecasts • Identify resource needs and establish contingency plans • Monitor Clinical Study Team resource utilization • Provide performance feedback on team members as required

🎯 Requirements

• Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred • Exceptions might be made for candidates with relevant clinical operations experience • 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 • Pivotal study management experience required • 5+ years of progressive experience in clinical research within biotech, pharma or CRO industry • Proficiency with MS Office, project planning applications, and clinical trial management systems • 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 • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness program • Reasonable accommodation in the job application process

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