我们欢迎专注于成果、乐于学习并能带来积极能量的同事加入我们。他们需要将主动性，团队合作和协作精神完美结合。最重要的是，他们必须为我们每天服务的消费者、患者和医疗行业人士做有意义的事情而充满热情。我们致力于赋能每位员工，促进他们的个人成长，同时确保当前和未来的业务需求得到满足。在高德美，我们拥抱多样性，尊重每一位员工的尊严、隐私和个人权利。我们坚信，致力于成为世界领先的专业皮肤学公司是我们共同的雄心抱负。加入我们，您将有机会获得具有挑战性的工作经历的绝佳机会，并创造无与伦比的直接影响
Job Title: (Senior) Clinical Project Manage
Location: Shanghai, China
Job Description
The Senior Clinical Project Manager plans and manages overall clinical operations for assigned global clinical trials/programs. This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables. This position ensures compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and aligns with company strategies and goals.
Key Responsibilities
61 Plan and Conduct Clinical Studies
61 Lead and manage multidisciplinary Clinical Trial Teams to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
61 Serve as the primary contact with CRO and act as team leader of the study work group.
61 Manage Subcontractors
61 May work with outsourcing manager to prepare clinical outsourcing specifications.
61 Participate in the selection of CRO.
61 Quality and Process
61 Contribute to and initiate process improvement initiatives.
61 Budget and Planning
61 Establish project milestones, budget and timelines for the study in partnership with the study team and outsourcing manager.
61 Project Team Representative (PTR)
61 Participate in the overall project planning and optimization with the Project Team.
61 Work closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the program.
61 Other duties may include managing CRA and CTA assigned to the study, as applicable
Skills & Qualifications
61 Bachelor’s degree, preferably in a biologic/scientific discipline is required.
61 Minimum of 12 years progressive experience in clinical operations including 6 years of clinical project management or equivalent with pharma, biotech device, and/or CRO is required.
61 Systemic route of administration clinical trials experience required; pediatric, drug/device combination device, and/or biologics experience preferred.
61 Thorough understanding of country-level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
61 Vendor management experience preferred
61 The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing duties of this job, the employee may or may not be frequently/or occasionally required to:
61 Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
61 Climb stairs or ride elevators.
61 Lift and/or move up to 25 pounds.
61 Use close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
61 Manipulate keyboard or otherwise access computer, telephone and hand-held devices.
61 Be exposed to outside weather conditions while going in and out of office buildings.
61 Be exposed to moderate noise level usually in warehouse settings.
61 Be exposed to moving equipment, mechanical parts, and/or high places; or moving between air-conditioned and non-air-conditioned environment
加入我们:
在高德美，您有机会获得具有挑战性的全新工作经历，并直接发挥无与伦比的影响力。我们供富有创新力和责任感的工作机会，您将在各个地区、不同职位的同事的支持下开展工作，他背景多元且同心协力，他们拥有共同的工作热情。
高德美是专注皮肤学领域的全球领导者，在大约90个国家和地区开展业务。我们为世界提供创新的、以科学为基础的优质旗舰品牌和服务组合，横跨注射美学、日常护肤和皮肤治疗这三个快速增长的皮肤学细分市场。自1981年成立以来，高德美一直热忱专注于人体***的器官——皮肤，与专业医务工作者合作，以卓越成果满足消费者和患者的需求。肌肤塑造了我们的人生，由此，高德美致力于不断推进“每一个进步 为每一寸肌肤”。高德美的旗舰品牌组合包括注射美学品牌瑞蓝、吉适、Azzalure、Alluzience和Sculptra，皮肤治疗品牌Soolantra、Epiduo、达芙文、Aklief、Epsolay、Twyneo、Oracea、Metvix、班赛和罗每乐，以及日常护肤品牌丝塔芙和Alastin。