全国
我们正协助一家全球化运营的外资全服务CRO寻访医学监察(肿瘤方向)。该公司在北美、欧洲及亚太地区设有运营团队,为生物技术和制药客户提供涵盖临床运营、项目管理、数据管理及法规事务的临床研发服务。 该职位将为指定项目提供医学监督、专业判断与医学支持,保障相关临床研究活动的顺利开展。岗位职级覆盖经理至总监级,具体职级将根据候选人的经验与能力确定。 We are supporting an international full-service CRO with global operations in the search for a Medical Monitor (Oncology). The company has operational teams across North America, Europe, and Asia-Pacific, providing biotech and pharmaceutical clients with clinical development services spanning clinical operations, project management, data management, and regulatory affairs. The successful candidate will provide medical oversight, expert judgment, and medical input across assigned clinical study activities. The opportunity is open at Manager through Director level, with the specific level determined based on the candidate’s experience and qualifications. Key Responsibilities • Serve as the Medical Monitor for assigned projects, providing medical oversight and input across relevant study activities. • Develop clinical strategies and development plans for Phase I–IV studies, and support their effective execution across assigned projects. • Prepare medical and scientific content for Requests for Proposal (RFPs), Bid Defense Meetings (BDMs), and other project-related presentations. • Participate in interactions with the Center for Drug Evaluation (CDE) and other relevant health or regulatory authorities. • Develop Medical Monitoring Plans (MMPs), coordinate internal review, align with sponsors, and ensure appropriate approval and filing. • Develop and deliver training on study protocols, disease areas, investigational products, mechanisms of action, and relevant medical or epidemiological data. • Interpret clinical study data and communicate relevant medical insights to internal study teams, including CRAs and Project Managers, as well as sponsor teams. • Contribute to process and resource improvements, and support recruitment, onboarding, or coaching activities when required. • Maintain current knowledge of assigned therapeutic areas, clinical development trends, competitive intelligence, and relevant market developments. Required Experience & Skills • A master’s degree or above in medicine or a related medical discipline. • At least three years of CRO experience, including experience with oncology clinical trials. • Working proficiency in written and spoken English, sufficient for meetings, medical documentation, and communication with sponsors and international teams. • Solid knowledge of clinical trial operations, ICH-GCP guidelines, and applicable regulatory requirements, with the ability to interpret clinical and safety data. • Strong medical writing, presentation, communication, and cross-functional collaboration skills.
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ApplyIndustry:制药 Pharmaceutical
Job Category:医学 Medical
Location:全国
Job Type:全职
15652098224