Global Clinical Study Manager

🔥 15 hours ago

🌐 Italy, France, +1 more countries – Remote

🇮🇹 Italy – Remote 🇫🇷 France – Remote 🇪🇸 Spain – Remote

💵 €63.9k - €92.6k / 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 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, and act as point of escalation • Align study goals with clinical operations and corporate goals and objectives • Lead external vendor management and collaborate with regional subject matter experts • Provide regular study progress updates to senior management • Lead planning and management from feasibility through closeout • Manage study timelines, feasibility, trial allocation, site selection, startup, and site activation • Ensure timely availability and quality of study documents for regulatory and ethics submissions • Create, maintain, and implement study plans, systems, tools, training records, and Trial Master Files • Implement risk-based quality management processes and support data cleaning timelines • Plan and execute Clinical Study Reports with Medical Writing and study team members • Monitor compliance with protocol, SOPs, ICH/GCP, study plans, and regulations • Manage quality metrics, inspection readiness, audits, inspections, risks, and corrective/preventive actions • Develop and share best practices and contribute to SOP and work-instruction improvements • Select and manage study vendors and approve invoice payments • Manage study budgets, forecasts, accruals, resources, and contingency plans • Ensure studies are executed within approved timelines, quality, and cost parameters • 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 and in-depth understanding 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

• Equal opportunity employment • Travel as required by business need

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