Clinical Supply Service Project Manager 临床供应链项目经理

岗位职责：

1. 作为CSS团队核心成员，与各职能团队紧密协作，统筹并协调临床供应时间表与策略；担任客户主要对接人（POC），主导定期项目进展会议。

Serve as a core member of the CSS team, collaborating cross-functionally with stakeholders to align and negotiate clinical supply timelines and strategies. Act as the primary point of contact (POC) for clients and lead regular project status meetings.

2. 能够根据客户的临床试验方案（Protocol / Statistical Analysis Plan），与第三方RTSM供应商共同完成随机化方案设计（如区组随机、分层随机、比例随机等）；或能够解读客户提供的随机化方案并指导贴签包装及仓储发货流程。

Collaborate with third-party RTSM vendors to design randomization schemes (e.g., block, stratified, ratio-based, or adaptive randomization) based on clinical trial protocols and statistical analysis plans (SAP); alternatively, interpret sponsor-provided randomization schemes and translate them into executable labeling,

packaging, warehousing, and distribution plans.

3. 理解并支持临床试验盲法实施策略（双盲、单盲、开放标签等）；能够支持紧急揭盲，计划性揭盲的相关工作。

Support implementation of clinical trial blinding strategies, including double-blind, single-blind, and open-label designs. Provide support for emergency unblinding, planned unblinding activities.

4. 协调内外部合作方，包括贴签与包装中心、进出口、法规事务、质量及供应链等职能，推进临床供应相关工作；针对公司自研及外部产品，发出物料采购、贴签包装及分发执行指令。

Coordinate with internal and external partners, including labeling and packaging, import/export, regulatory affairs, quality, and supply chain functions, to manage clinical supply activities. Issue execution instructions for material sourcing, labeling/packaging, and distribution for both in-house and external products.

5. 在SAP/IRT系统中，为所有研究产品需求（原料药与临床成品）建立并维护统一可视化库存管理

Manage and maintain end-to-end inventory visibility within SAP/IRT systems, covering both bulk drug substance/drug product and clinical finished goods.

6. 分析预测临床供应链交付风险，制定缓解策略并与临床合作伙伴及管理层审议

Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders.

7. 参与盲态项目相关文件的编写与维护，确保全流程相关工作符合 GCP、ICH 及相关监管要求和公司内部 SOP；并在客户或监管机构沟通中就随机化及盲法提供专业解释或客户有关随机化和盲法的解释与沟通工作。

Contribute to the development and maintenance of documentation for blinded studies, ensuring all process-related activities comply with GCP, ICH, relevant regulatory requirements, and company SOPs; support audit readiness and provide subject-matter expertise on randomization and blinding in client and regulatory interactions.

8. 对分配工作具有高度责任感和担当, 必要时支持团队建设

Demonstrate strong ownership and accountability for assigned responsibilities; contribute to team development and continuous improvement initiatives as needed.

岗位要求：

• 供应链管理、药学、生物技术、生物统计学、流行病学或相关专业本科及以上学历。

Bachelor's degree or higher in Supply Chain Management, Pharmacy, Biotechnology, Biostatistics, Epidemiology, or related fields

• 或2–5 年临床II-III期试验相关工作经验（CRO、药企或临床供应链相关经验均可）；

Or 2-5 years of experience in Phase II-III clinical trials (experience in CROs, pharmaceutical companies, or clinical supply chain is acceptable).

• 具有随机化表制作及 RTSM 系统对接经验者优先。

Preference given to candidates with experience in randomization schedule development and RTSM system integration.

• 具有过揭盲、临床II-III期审计、贴签包装执行经验者优先。

Preference given to those with hands-on experience in unblinding procedures, Phase II-III audits, and labeling/packaging operations.

• 能使用SAS,R, Python 或类似随机化工具者优先；

Experience with SAS, R, Python or similar randomization tools is a plus.

• 熟悉常见随机化方法及其在临床试验中的实际应用；

Familiar with commonly used randomization methodologies and their application in clinical trials.

• 能理解Dummy Run / UAT 测试流程。

Able to understand dummy run and UAT testing processes.

• 熟悉临床试验相关法规和指导原则（如 ICH-GCP 及随机、盲法相关要求）；

Familiar with clinical trial regulations and guidelines, including ICH-GCP and requirements related to randomization and blinding.

• 具备良好的合规意识和规范的文档管理意识；

Strong compliance mindset with good documentation practices.

• 具备良好的英文沟通能力，能够与临床运营、RTSM 供应商、QA 等多方协作；

Strong communication skills in English with the ability to collaborate effectively with Clinical Operations, RTSM vendors, and QA teams.

• 工作细致、逻辑清晰，对数据和流程具有较强责任感；

Detail-oriented with strong logical thinking and ownership of data and processes.

• 能在指导下独立完成模块性工作，而非完全依赖指令执行。

Capable of independently handling assigned tasks with guidance, rather than relying solely on step-by-step instructions.