Senior Medical Monitor Manager

Senior Medical Monitor Manager Who We Are Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies . With over 25 years of experience and a world-renowned focus in renal research , Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward. About the Role Provide medical oversight and support for clinical trials, ensuring studies are conducted safely, compliantly and scientifically per GCP and the protocol. Act as senior medical contact for clinical development, protocol input, medical review, safety assessment and client/regulatory interactions. 负责临床试验的医学监督与支持，确保试验按GCP和方案要求安全、合规、科学地开展，作为高级医学联系人支持临床开发、方案设计、医学评审、安全评价与客户/监管沟通。 Responsibilities Review and provide medical input for study protocol, informed consent form (ICF), Investigator’s Brochure (IB), statistical analysis plan (SAP), and other study documents. 审阅和提供医学意见于试验方案、知情同意书（ICF）、研究手册（IB）、统计分析计划（SAP）等文件。 Participate in study start-up, monitoring and closeout activities (if needed); provide medical training and support to monitors and project teams，include but not limited to investigator meeting, data monitoring committee and safety monitoring(review) committee etc. 参与研究启动、监查、关闭（如需要）等关键活动并为监查员或项目团队提供医学培训与支持，包括不限于研究者会议、数据审查委员会以及安全监查委员会等。 Conduct medical review of clinical data (listing or profile data), identify data quality or safety issues and propose remedial actions. 支持临床数据的医学审核（列表或profile数据等），识别数据质量或安全性问题并提出纠正建议。 Assess and manage adverse events (AEs/SAEs), perform medical adjudication, causality assessment and follow-up recommendations; prepare/review medical reports. 负责评估和处置不良事件（AE/SAE），对SAE进行医学判定、因果关系评估及随访建议；撰写/审阅相关医疗报告。 Communicate with site investigator，sponsors, safety monitoring(review) committee, pharmacovigilance teams and regulatory authorities on medical matters, providing timely medical advice and documentation. 与研究中心、申办方、安全监测委员会、药物警戒团队和监管机构沟通医学问题，提供及时的医学意见和文件支持。 Serve as company medical representative in client meetings, support RFPs（bidding） and engage in medical communications with IRBs/ethics committees and regulators. 作为公司医学代表参与客户会议、投标（竞标）支持以及与伦理委员会/监管机构的沟通与答复。 Complete other activities or tasks assigned by Medical Director. 完成医学总监指派的其他活动和任务。 In some case role of Safety Physician may be taken. Responsibilities ： 在一些情况下，可能会承担安全医生的职责： Conduct medical safety relevant tasks according to regulation and internal procedural documents, including product safety monitoring, review and preparation of safety report, Risk Management Plan, DSUR, PSUR etc. 根据法规及内部流程文件开展医学安全相关工作，包括不限于产品安全监测、审核/准备安全性报告，以及风险管理计划、开发期间安全性更新报告、定期安全性更新报告等。 Keep close collaboration with Medical Director/Manager (if safety physician and medical monitor are not the same person in one project), DS personnel provide in-depth evaluation and solution for safety issues. 与医学总监/医学经理（若安全医生和医学监查并非同一个人时）、药物警戒团队保持紧密协作，对安全性问题进行深入评估并提出解决方案。 About You Fluent written and good verbal English skill, able to communicate with international clients and regulators 流利的英文书面表达和良好的口头表达能力，能与国内外客户及监管进行沟通 Ability to work independently and handle multiple tasks simultaneously under pressure 能够独立工作并在压力下同时应对多项任务 Excellent communication skills and cross-functional coordination and problem-solving skills. 优秀的沟通技巧、跨部门协调与解决问题能力 Global, cross-cultural perspectives and customer orientated 全球性、跨文化的视角以及以客户为导向的理念 Clinical Medicine education background, Master’s degree or above is preferred 7-10 years’ or above working experience and 5+ years of medical monitoring or medical manager（CRO or Sponsor preferred） Minimum 2 years of hands‑on clinical practice experience as a physician. Prior oncology trial monitoring experience required. 临床医学教育背景，硕士或以上优先 7-10年或以上工作经验，包括3-5年以上医学监查或医学经理经验（在CRO或制药公司为佳）。 有至少2年或以上实际医生经验 有肿瘤项目监查经验 Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s what makes us stand out: • Purpose-Driven Work : You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. • Global Reach, Local Expertise : Our teams connect with local communities, building trust and meaningful engagement for every trial. • Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: • Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience. • Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role. • Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. • Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. • Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates. Department Medical Monitoring Role Senior Medical Monitor Locations Multiple locations Remote status Hybrid Employment type Full-time