Associate Clinical Research Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $105.8k - $140.8k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 1%

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Logo of BeOne Medicines

BeOne Medicines

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 • Ensure compliance with ICH-GCP, local regulations, and company SOPs • Lead the CRA team to achieve organizational goals and high performance • Allocate CRA resources and assess workload to meet study deliverables • Ensure CRAs have the monitoring knowledge and skills needed to perform activities with high quality • Manage CRA performance and quality indicators • Strengthen site relationships to enhance performance and trial delivery • Review monitoring quality and resolve compliance issues • Support study and site milestone delivery with cross-functional teams • Execute assessment visits and accompanied visits where required • Identify issues and develop resolution strategies • Contribute to process optimization and manage risk escalation and resolution • Support site audits, inspections, and Site Compliance Visits • Ensure corrective action and follow-up for identified issues • Recruit, hire, and onboard team members • Assign tasks based on individual strengths and team objectives • Provide team members with resources and support • Encourage communication and collaboration within the team and with other functions • Conduct performance evaluations and provide constructive feedback • Mentor team members and support their professional development • Address personnel issues promptly and fairly

🎯 Requirements

• Proficient in Microsoft Word, Excel, PowerPoint and Outlook • Fluent in written and verbal English • Minimum 5 years of industry experience in the pharmaceutical or CRO or relevant field • Thorough understanding of the drug development process • Expert knowledge of international standards (ICH-GCP) and health authority requirements • Understanding of all aspects of monitoring and trial execution • Previous experience as a CRA preferred • Excellent interpersonal skills • Strong organizational skills • Effective written and verbal communication skills • Experience in Oncology highly recommended • Adaptable to business trips as required per business need • Valid driver’s license in applicable countries • Bachelor’s degree or higher in a scientific or healthcare discipline • Advanced degrees preferred

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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