北京招聘

POSITION SUMMARY:

Assists in testing of databases and maintenance of study data, including the processing of discrepancies and queries. Assists in reviewing CRFs, data listings and database to ensure that all captured data follow the rules outlined by the protocol and data management plan.

RESPONSIBILITIES:

• Assists in maintaining databases and performing database updates

• Reviews CRFs, data listings and database to ensure that all captured data follow the rules outlined by the protocol, data management plan, and other data management documents

• Generates paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates, client representatives) to resolve problematic data identified during every aspect of the data management process

• Reviews responses to queries for appropriateness, resolves any discrepancies and ensures that the database is modified accordingly

• Tracks CRFs

• Reconciles external data from other vendors

• All other projects as assigned

  Other

• Quality control reviews output of the clinical database (entry screens or data listings) against primary documents (e.g., data management plan, case report forms and queries) for data accuracy, consistency and application of predetermined conventions

• Assists in writing quality control reports in a timely and concise manner according to standard operating procedures

  EDUCATION, SKILLS & COMPETENCIES:

1. Educational Background

• Educated to Bachelor’s degree level, or equivalent. In lieu of this qualification, 1 year of experience in clinical research, drug development or healthcare environment will be required

1. Experience

• Understanding and experience with up to date MS Windows Operating Systems and applications

• Working knowledge of medical terminology and experience with clinical research preferred

1. Expertise and know-how

• Attention to detail and able to independently resolve a variety of issues without close supervision

1. Personal skills & behaviours

• Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.

• Excellent team player, collaborative and able to build an effective team.

• Ability to multitask and work effectively in a fast-paced environment with changing priorities.

• Strong verbal and written communication and negotiation skills.

• Excellent organizational and time-management skills, able prioritize work to meet deadlines.

• Accountable, dependable and strong commitment.

• Is customer service focused in approach to work both internally and externally.

• Maintains a positive, results orientated work environment.

The above job description is intended to describe the key responsibilities but is not an exhaustive summary of all responsibilities, duties and skills that are required. The company reserves the right to vary the job descriptions as per their requirements.

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.