工作地点：中国广州 （可适当出差）
Work Location ： GuangZhou City，China / Occasional Business Travel required
岗位概述
Position Summary
该岗位负责公司临床工作整体管理与推进，具备扎实的医学背景（职业医师，精神科执业医师优先），同时有丰富的临床招募管理、项目执行、团队管理经验。需具备优秀的英文交流及跨文化沟通能力，以支持全球/多中心临床试验的顺利进行。
This position is responsible for the overall management and advancement of the company’s clinical operations. The ideal candidate will have a solid medical background (licensed physician, preferably with a specialization in psychiatry), along with extensive experience in patient recruitment management, project execution, and team leadership. Strong English communication skills and cross-cultural competencies are essential to support the smooth conduct of global and/or multi-center clinical trials.
主要工作职责 Key responsibilities
1.临床项目管理 / Clinical Project Management
1.1全面公司临床项目试验的设计、实施与质量监控的全面工作
Oversee the full scope of the company’s clinical trial design, implementation, and quality monitoring.
1.2制定项目计划、时间表和预算，并确保达成关键里程碑。
Develop project plans, timelines, and budgets, ensuring the achievement of key milestones.
1.3协调内部团队与客户、医院等相关机构的合作；
Coordinate collaboration between internal teams and stakeholders such as clients, hospitals,
and other relevant institutions.
2. 临床受试者招募管理 / Clinical Patient Recruitment Management
2.1制定并执行受试者招募策略，确保招募目标按期完成。
Develop and implement patient recruitment strategies to ensure enrollment targets are met on schedule.
2.2建立与维护临床试验中心、医生、患者组织的良好合作关系。
Establish and maintain strong relationships with clinical trial sites, investigators, and patient organizations.
2.3核查和确认受试者入组条件与入组记录，确保所有入组信息的完整性与准确性，并符合试验方案及相关伦理、法规要求
Review and verify subject enrollment eligibility and records to ensure completeness and accuracy of all enrollment information, in compliance with the study protocol and applicable ethical and regulatory requirements. Communicate with relevant teams as needed to promptly correct or supplement information.
2.4 监控招募进度及质量，及时优化流程。
Monitor recruitment progress and quality, and promptly optimize processes when necessary.
3. 医学与科学支持 / Medical and Scientific Support
3.1提供医学专业意见，参与研究方案、知情同意书等核心文件的撰写与审核。
Provide medical expertise and participate in the drafting and review of core documents such as study protocols
and informed consent forms.
3.2 解答研究相关的医学问题，培训团队成员与研究中心人员。
Address medical questions related to the study and deliver training to team members and site staff.
3.3 参与安全性事件评估及医学决策。
Participate in the assessment of safety events and contribute to medical decision-making.
4. 合规与质量保证 / Compliance and Quality Assurance
4.1 确保项目遵循ICH-GCP、相关法律及伦理要求。
Ensure that projects comply with ICH-GCP, relevant laws, and ethical requirements.
4.2 负责应对监管机构及伦理委员会的沟通与检查。 Manage communications and inspections with regulatory authorities and ethics committees
5. 团队建设与领导 / Team Building and Leadership
5.1管理并培养临床运营团队，提升专业能力与执行力。 Build, manage, and develop the clinical operations team to enhance professional competence and execution capabilities.
制定KPI并进行绩效评估。 Set KPIs and conduct performance evaluations.
任职资格Qualification
1.医学硕士及以上学历，执业医师，职业医师，精神科执业医师优先 。 Master’s degree or higher in Medicine; licensed medical practitioner, with preference given to those qualified in Psychiatry.
2.5–10年及以上临床试验管理经验，其中至少2–3年精神科临床项目经验。
5–10 years of experience in clinical trial management, including at least 2–3 years in psychiatry-related clinical projects.
3.深入理解临床试验流程、GCP及相关法规。
In-depth understanding of clinical trial processes, GCP, and applicable regulations.
4.英文口语和书面表达流利，能独立进行国际会议沟通。
Fluent in both spoken and written English, with the ability to independently engage in international meetings.
5.具备优秀的项目管理能力、跨部门协调能力和团队领导力。
Strong project management skills, cross-functional coordination capabilities, and leadership abilities.
6.逻辑思维清晰，抗压能力强，能应对紧急状况。
Clear logical thinking, resilience under pressure, and the ability to handle urgent situations effectively.
优先条件Preferred
1.有跨国临床公司管理经验。
Management experience in multinational clinical research companies.
2.参与过多中心、国际临床试验的全流程管理。
Experience managing the full lifecycle of multi-center and international clinical trials.
3.熟悉精神科患者社群资源，有一定社会化招募渠道。
Familiarity with psychiatric patient communities and established channels for patient recruitment.