Clinical Research Manager

🔥 0 minutes ago

🇹🇷 Turkey – Remote

💵 ₺2.2M - ₺2.8M / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 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 for compliance with ICH-GCP, local regulations and company SOPs • Allocate CRA resources and assess workloads to meet study deliverables • Ensure CRAs maintain the knowledge and skills needed to perform monitoring activities with high quality • Manage CRA performance and quality indicators • Strengthen site relationships and support trial delivery • Review monitoring quality, resolve compliance issues and support study/site milestones • Execute assessment visits and accompanied visits where required • Contribute to process optimization and manage risk escalation and resolution • Support site audits, inspections and Site Compliance Visits, including corrective actions and follow-up • Review and approve CRA-related expenses and identify cost-saving opportunities • Recruit, hire, onboard, assign tasks, support, evaluate, mentor and develop team members • Address personnel issues and support career development • Promote communication, collaboration and a positive team culture

🎯 Requirements

• Bachelor’s degree or higher in a scientific or healthcare discipline; advanced degrees preferred • 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 • Minimum 2 years of people management or project management experience in progressive clinical research 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; previous CRA experience preferred • Excellent interpersonal, organizational, written and verbal communication skills • Demonstrated team leadership experience • Oncology experience highly recommended • Adaptability to business trips as required • Valid driver’s license in applicable countries

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