Clinical Research Manager - Oncology & CRA Leadership

BeOne Medicines USA; United States; Vor Ort; USD 106.000 - 141.000; Vollzeit

Zusammenfassung

BeOne Medicines USA is seeking an Associate Clinical Research Manager to oversee clinical monitoring activities and lead the CRA team. You will ensure compliance with ICH-GCP, local regulations, and company SOPs while promoting a high-performance and collaborative culture.

As a line manager, you will allocate CRA resources, mentor staff, and drive site-quality and trial delivery. Extensive oncology experience and strong communication are highly valued.

Qualifikationen

• Bachelor's degree or higher in a scientific or healthcare discipline, advanced degrees preferred.
• Minimum 5 years of industry experience in the pharmaceutical or CRO or relevant field
• Thorough understanding of ICH-GCP and health authority requirements
• Understanding of monitoring and trial execution, with previous experience as a CRA preferred
• Excellent interpersonal, organizational and communication skills
• Experience in Oncology is highly recommended

Aufgaben

• Allocate CRA resources and perform ongoing resource assessments to balance workload and meet study deliverables.
• Ensure CRAs have required monitoring knowledge and skills to perform activities with high quality.
• Manage CRA performance and quality indicators per ICH-GCP and SOPs.
• Strengthen site relationships to enhance performance and uphold trial delivery reputation.
• Review monitoring quality and resolve issues to ensure regulatory compliance.
• Support site audits/inspections and follow-up on corrective actions.
• Recruitment and onboarding of new team members; assign tasks and provide resources.
• Mentor and develop team members; promote a culture of growth.

Jobbeschreibung

BeOne Medicines USA is seeking an Associate Clinical Research Manager to oversee clinical monitoring activities and lead the CRA team. You will ensure compliance with ICH-GCP, local regulations, and company SOPs while promoting a high-performance and collaborative culture.

As a line manager, you will allocate CRA resources, mentor staff, and drive site-quality and trial delivery. Extensive oncology experience and strong communication are highly valued.