北京招聘

Responsibilities:

• Accountable to correctly implement the design of the protocol into the Data Sciences trial-specific systems specifications for all assigned trials
• Accountable to produce a system test plan that, when executed as designed, will produce a clinical-trial system that is fit for purpose and adequate for statistical analysis.
• Accountable for the preparation and facilitation of Clinical Technology review meetings with cross-functional team members from Statistics, Statistical Programming, Clinical Program Development, etc.
• Accountable for supporting and utilizing Data Sciences policies and procedures.
• Reviews and approves Data Management Plans for all trials
• Reviews and approves Case Report Forms and Completion Guidelines for all trials
• Promotes and enforces responsible use of data standards
• Ensures resources are trained and available for all data management projects
• Drives efficiency by identifying and creating solutions and tools.
• Ensures database designs and data operations are consistent and conform to standard processes
• Ensures proper documentation is filed in the Trial Master File
• Participates in budget development both for projects and for the department budgets
• Liaise with cross functional team and external contacts to execute all aspects of data management trial delivery
• Ensures data management problems are identified early in the lifecycle and are followed through to resolution
• Manages vendors for systems and software used by Data Management
• Ensures the integrity of data, providing recommendations for corrective action when necessary
• Ensures all deliverables are on time and on budget for all data management projects
• Keeps management abreast of issues, progress, and risks related to trial operations

Job Requirements:

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent is required. Master's or advanced degree is desired
• Must have 2+ years of direct data management experience or 4+ years of experience in a similar technical environment
• Must have experience designing systems and creating system specifications.
• Must have demonstrated experience in influencing teams during the design, conduct, and completion of trials.
• Demonstrated effective communication skills.
• Must demonstrate analytical skills and ability to identify signals and potential issues with clinical systems, and development of plans to address

和铂医药是一家专注于肿瘤免疫领域创新药物研究与开发的全球化运营生物医药公司。公司将运用其拥有的全部自主知识产权的全人源单抗的转基因鼠系列核心技术平台，建立下一代治疗性肿瘤抗体药物产品管线,并将围绕Harbour的两大平台拓展合作与授权业务。公司总部及研发基地位于中国上海，另外在美国马塞诸塞州剑桥设立商业运营中心，在荷兰鹿特丹设立抗体研发平台创新中心，在波士顿地区设立了创新中心包括实验室和研发团队，也将在江苏昆山设立研发基地。公司拥有资深管理团队以及丰富的药物研究与开发经验。和铂医药要为满足中国及全球病人的需求而不断努力，依托拥有自主知识产权的核心技术平台,创建一个在肿瘤治疗领域有科学与技术领导力的国际性生物医药公司。同时, 在药物研发领域建立以技术平台为基础的对外合作，整合新的技术，推动中国整个抗体研发产业的进步。

Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.