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 external partners • Act as escalation point for regional study issues and ensure alignment with overall study goals • Lead planning and management of assigned clinical studies from feasibility through closeout • Manage study 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 study submissions to regulatory authorities and ECs/IRBs • Maintain current regional and country information in study systems and tools • Collaborate with CRAs to ensure proper site execution and review and sign off monitoring reports • Ensure country and site-level Trial Master Files are created, maintained, and quality-controlled • Provide input on regional drug inventories, labels, comparator drug regulatory approval, and reimbursement status • Manage regional trial data collection, data entry, and query resolution • Support Clinical Study Report planning and execution • Monitor regional compliance with protocol, SOPs, ICH/GCP, and applicable regulations • Ensure inspection readiness and prepare sites for quality assurance audits and inspections • Drive responses to audit and inspection findings • Share learnings and best practices and improve study efficiency and quality • Manage regional vendors, budgets, investigator fees, site payments, patient travel reimbursement, and resource needs

🎯 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 biotech, pharma, or CRO industry • Proven clinical research experience, including relevant team-lead experience in clinical functions • Experience as a CRA preferred • Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook • Ability to manage clinical study timelines, budgets, vendors, regulatory submissions, TMF quality control, and ICH/GCP compliance • Ability to travel as required by business need

🏖️ Benefits

• Travel might be required as per business need • Higher Degree preferred • Mentoring opportunities for junior team members