(高级)经理,临床研究中心区域负责人
云顶新耀医药科技有限公司职位描述
Position Summary: 职位概述: Line manager of site management team in designated region, ensure site start up, delivery and quality via oversight to team members. Managing the resource and develop capability of team to enable Drug Development portfolio success. Support head of Clinical Site Management to develop site cooperation strategy which can ensure continuous success of clinical studies.
Key Responsibilities 主要职责 Provide supervision, coaching and performance oversight to site management team in the region responsible, ensuring site start-up timeline, data quality, patient safety reporting and regulatory compliance at site level for all the in-house studies. Develop site partnership strategies in the region responsible for accelerating site activation and maintaining high-quality site performance. Build up clinical site database matching Drug Development Portfolio to guide the site selection best fit for the studies. Partner with Clinical Operations Lead to facilitate study site selection activities to ensure appropriate sites are selected for studies to meet Drug Development strategy. Support team members to achieve site enrolment targets. Support team members and study team to solve the issue related to site management. Establish and maintain solid relationship with clinical sites and provide onsite support and issue resolution as needed. Undertake resource planning and management to guarantee adequate resources to support all clinical studies. Lead end-to-end team recruitment, including talent sourcing, interviewing, hiring and onboarding; oversee team training, performance management and career development to build a high-performing team and meet organizational talent needs.
Recommended
Education and Key Competency Basic Qualifications • Minimum bachelor’s degree major in medical, biology, pharmacology or other life science disciplines • Minimum 6 years of clinical operation experience covering site management, quality management, with exposure to project management. Preferred Qualifications • Study management experience at country level for multi-country study • People management experience in CO • Working experience Global pharmaceutical company and/or global CRO working experience Professional Knowledge • Extensive knowledge of ICH/GCP regulations and guidelines • Advanced knowledge of China clinical trial management including regulations and guidelines • Solid understanding of Clinical trial processes and operations • In-depth insight of operational excellence in clinical studies • Broad knowledge across multiple therapeutic areas. Core Competencies • Scientific • Strategic Risk Management • Change Agility & Learning Agility • Project and Operational Excellence • Stakeholder Engagement • Quality Management • Breakthrough Analysis (Analytical Thinking and Innovation) • Organizational Savvy • Joint Value Creation (Courage/Speak Up) • Resource Planning & Management • Interpersonal Savvy • Team leadership & people management Language:
- Chinese & Business English fluency
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