Senior Clinical Research Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $136.4k - $181.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

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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

• Oversee clinical monitoring activities and CRA team performance • Allocate CRA resources and assess workloads to meet study deliverables • Ensure CRAs perform monitoring activities with appropriate knowledge, skills, quality, and compliance • Manage CRA performance and quality indicators according to ICH-GCP, SOPs, and local regulations • Strengthen site relationships and uphold trial delivery quality • Review monitoring quality and resolve regulatory and compliance issues • Support study and site milestone delivery with cross-functional teams • Execute assessment visits and accompanied visits to assess CRA monitoring competency • Identify issues and develop resolution strategies • Contribute to process optimization and manage risk escalation and resolution • Support site audits, inspections, and Site Compliance Visits, including corrective action follow-up • Review and approve CRA activity expenses • Identify cost-saving and efficiency opportunities while maintaining quality and compliance • Mentor junior Clinical Research Managers • Lead and contribute to clinical operations taskforces and strategic initiatives • Recruit, hire, and onboard team members • Assign tasks and provide resources to support team productivity • Encourage communication and collaboration and act as an escalation contact • Conduct performance evaluations and provide feedback • Lead team mentoring, development, issue resolution, and career development support

🎯 Requirements

• Bachelor’s degree or higher in a scientific or healthcare discipline • Fluent in written and verbal English • Minimum 7 years of industry experience in the pharmaceutical, CRO, or relevant field • Minimum 4 years of people management or project management experience in progressive clinical research is preferred • Thorough understanding of the drug development process • Expert knowledge of international standards, including ICH GCP, and health authority requirements • Understanding of monitoring and trial execution • Previous CRA experience is preferred • Excellent interpersonal, organizational, written communication, and verbal communication skills • Demonstrated team leadership experience • Oncology experience is highly recommended • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook • Adaptability to business trips as required • Valid driver’s license in applicable countries

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Reasonable accommodation support