Senior Clinical Research Manager

🕒 May 15

🏄 California – Remote

🏄 California – Remote

💵 $136.4k - $181.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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BeOne Medicines

WebsiteLinkedInAll Job Openings

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