BeOne Medicines
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.
Regional Clinical Study Manager
🔥 0 minutes ago
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BeOne Medicines
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
• Lead regional clinical operations teams and oversee external partners for assigned studies • Act as the escalation point for regional study issues and ensure alignment with overall study goals • Collaborate with regional stakeholders and provide study progress updates to senior management and the Global Clinical Study Manager • Represent regional study teams at internal and cross-functional Clinical Study Team meetings • Plan and manage assigned clinical studies from feasibility through regional closeout • Manage study start-up and recruitment timelines and track regional progress • Drive regional trial feasibility, country allocation, and site selection • Coordinate local adaptations of global study documents and country submissions to regulatory authorities and ECs/IRBs • Maintain accurate regional and country information in study systems and tools • Collaborate with CRAs to ensure proper site execution and review/sign off monitoring reports • Ensure country and site-level Trial Master Files are created, maintained, and quality-controlled • Provide input on regional drug inventories, local drug labels, comparator drug regulatory approvals, and reimbursement status • Manage regional trial data collection, data entry, and query resolution • Support Clinical Study Report planning and execution • Monitor study compliance with protocols, SOPs, ICH/GCP, and relevant regulations • Ensure inspection readiness, prepare sites for audits and inspections, and drive responses to findings • Lead process improvements and contribute to work instructions and SOPs • Select and manage regional study vendors and manage regional study budgets • Coordinate investigator fees, site payments, patient travel reimbursement, and regional resource needs • Provide performance feedback and mentor junior team members as required
🎯 Requirements
• Bachelor’s Degree in a scientific or healthcare discipline required • Higher Degree preferred • MS Office proficiency • Project Planning Applications proficiency • 4 or more years of progressive clinical research experience in biotech, pharma, or CRO industry • Proven clinical research experience, including relevant team-lead experience in clinical functions • CRA experience preferred
🏖️ Benefits
• Market competitive compensation package • Performance-based annual bonus scheme • Company shares (generous welcome grant!) • In-house and external learning and development opportunities • Fantastic benefits program • Dynamic, collaborative, supportive, inclusive, and fun team environment
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