Regional Clinical Study Manager

đŸ”„ 42 minutes ago

đŸ—ŁïžđŸ‡«đŸ‡· French Required

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

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 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 appropriate inspection-ready quality, within agreed timelines and budget. ‱ Lead the regional clinical operations team and act as point of escalation for issue resolution. ‱ Ensure alignment of regional deliverables with overall study goals. ‱ Collaborate with key stakeholders in the region and provide regular updates on study progress. ‱ Generate, manage, and maintain high-quality study start-up and recruitment timelines for the region. ‱ Ensure timely availability of local adaptations of global study documents and submissions to regulatory authorities. ‱ Work closely with CRAs in the region to ensure proper study execution at sites. ‱ Handle escalated issues or problems with sites in the region. ‱ Monitor regional study activities for compliance with the study protocol, SOPs, and ICH-GCP.

🎯 Requirements

‱ Bachelor’s degree in a scientific or healthcare discipline required; advanced degree preferred. ‱ Minimum of 4 years of progressive experience in clinical research within biotech, pharma, or CRO environments. ‱ Proven experience in clinical research, including relevant experience as a team lead in clinical functions. ‱ CRA experience preferred. ‱ Proficient in Microsoft Word, Excel, MS Project, PowerPoint, and Outlook.

đŸ–ïž Benefits

‱ Health insurance ‱ Professional development ‱ Flexible work arrangements ‱ Paid time off ‱ Wellness programs ‱ Performance-based feedback

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