Regional Clinical Study Manager

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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 regional study delivery with inspection-readiness quality, within agreed timelines and budget • Lead the regional clinical operations team and oversee regional external partners • Act as the regional escalation point for assigned-study issues • Align regional deliverables with overall study goals • Lead study planning and management from feasibility through closeout • Manage start-up and recruitment timelines and track regional progress • Drive trial feasibility, country allocation, and site selection • Coordinate local adaptations of global study documents and regulatory/ethics submissions • Maintain accurate regional and country information in study systems • 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 clinical supplies, drug inventories, labels, comparator-drug approvals, and reimbursement status • Manage regional data collection, data entry, and query resolution • Support Clinical Study Report planning and execution • Monitor compliance with protocol, SOPs, ICH/GCP, and applicable regulations • Ensure regional inspection readiness and prepare sites for audits and inspections • Share learnings and best practices and improve study efficiency and quality • Select and manage regional vendors and budgets • Manage investigator fees, site payments, and patient travel reimbursement activities • Identify resource needs, establish contingency plans, and monitor resource utilization • Provide performance feedback and mentor junior team members • Line-manage study start-up and trial-monitoring staff, including work allocation, performance appraisals, hiring input, and development plans

🎯 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 • 4 or more years of progressive experience in clinical research within the biotech, pharmaceutical, or CRO industry • Proven clinical research experience, including relevant team-lead experience in clinical functions • CRA experience preferred • Efficient proficiency in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook • Willingness to travel as required by business needs

🏖️ Benefits

• Salary range of 74,100.00 EUR - 92,600.00 EUR • Travel might be required as per business need • Mentoring and professional development support for direct reports