(Senior) Clinical Research Manager

General Description: The Clinical Research Manager oversees clinical monitoring activities and the CRA team's performance to ensure they comply with ICH-GCP, local regulations, and company SOPs, and maintain quality across clinical trials. As a line manager, this role leads a team to achieve organizational goals and ensure high performance by providing guidance, support, and development opportunities while promoting a positive team culture. Essential Functions of the Job: •Team Resource Allocation & Performance -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 to successfully perform required activities with high quality to meet study deliverables. -Is responsible for managing and addressing CRA performance and quality indicators in accordance with ICH-GCP, SOPs and local regulations. -Strengthen site relationships to enhance performance and uphold the company’s trial delivery reputation. •Quality and Compliance -Review monitoring quality and resolve issues to ensure compliance with regulatory guidelines, ICH-GCP Guidelines, and Good Clinical Practices. -Support study/site milestone delivery in collaboration with cross-functional teams. -Responsible for execution of assessment visits and accompanied visits (where required) to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies. -Contribute to process optimization initiatives and manage risk escalation and resolution. -Support site audits/inspections/Site Compliance Visits (SCV) and ensure corrective action and follow-up for identified issues. •Expense Review and Management -Review and approve expenses related to CRA activities to ensure alignment with applicable policies and financially best local practices. -Identify opportunities for cost-saving and efficiency while maintaining quality and compliance standards. Supervisory Responsibilities: •Recruitment and Onboarding: Performs recruiting and hiring activities, along with onboarding new team members to ensure alignment with team objectives and culture. •Task Assignment: Assign tasks based on individual strengths and team objectives, ensuring optimal productivity. •Support and Resource Provision: Support team members by providing necessary resources to help them effectively perform their roles. •Communication and Collaboration: Encourage open communication and collaboration within the team and with other functions, including a point of contact for issue escalation and feedback where required. •Performance Evaluation: Conduct regular performance evaluations and provide constructive feedback to promote continuous improvement. •Mentoring and Development: Lead and mentor team members, fostering an environment of growth and development. •Issue Resolution: Address any personnel issues promptly and fairly to maintain a positive work environment. •Career Development Support: Support team members in identifying and pursuing professional development opportunities. Computer Skills: Proficient in Microsoft Word, Excel, PowerPoint and Outlook Other Qualifications: •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 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. Travel: Be adaptable to business trips as required per business need; require valid driver’s license in applicable countries 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. 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