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.
Senior Clinical Research Manager
🕒 May 15
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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
• Oversee clinical monitoring activities and the CRA team's performance to ensure compliance with ICH-GCP, local regulations, and company SOPs • Allocate CRA resources and perform ongoing resource assessments to ensure a balanced workload for quality monitoring and to meet study deliverables • Ensure CRAs have the required level of monitoring knowledge and skills • Manage and address CRA performance and quality indicators • Strengthen site relationships to enhance performance and uphold the company’s trial delivery reputation • Review monitoring quality and resolve issues to ensure compliance with regulatory guidelines • Support study/site milestone delivery in collaboration with cross-functional teams • Review and approve expenses related to CRA activities • Identify opportunities for cost-saving and efficiency • Provide mentorship and guidance to junior Clinical Research Managers (CRMs) • Lead and contribute to strategic initiatives and task forces
🎯 Requirements
• Fluent in written and verbal English • Minimum 7 years of industry experience in the pharmaceutical or CRO or relevant field • Minimum 4 years of People management or project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field is preferred • Thorough understanding of the drug development process, including expert knowledge of international standards (ICH GCP) and health authority requirements • Understanding of all aspects of monitoring and trial execution, with previous experience as a CRA preferred • Excellent interpersonal skills, strong organizational and effective written and verbal communication skills. Demonstrated team leadership experience. • Experience in Oncology is highly recommended.
🏖️ Benefits
• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness
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