上海招聘

POSITION SUMMARY:

Responsible for the successful operation of projects and management of assigned personnel. Maintains ultimate responsibility for all assigned projects and direct reports. It is also expected that the individual will participate in initiatives for improving quality, efficiency, and resourcing.

RESPONSIBILITIES:

• Participates in EDC vendor selection

• Creates system validation plan

• Performs system validation

• Sets up studies in selected EDC database

• Contributes to EDC improvement

• Develops SOPs for database development

• Ensures review is completed on draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, and that feedback is provided to the project team, as necessary

• Provides oversight of project progress including resolution plans for unexpected challenges, if needed

• Provides support to subordinates in Database Development practices and related technical issues, if needed

• Mentors Database Developers, if applicable

• Manages personnel (Database Developers) with respect to Biometrics Technical Operations skill development and training, career development, issue resolution, in-depth evaluation of staff, and adherence to SOPs/Guidelines and GCP standards, if applicable

• May be required to undertake other programming tasks

EDUCATION, SKILLS & COMPETENCIES:

1. Educational Background

• Educated to Bachelor’s degree level, or equivalent. In lieu of this qualification, 3 years of experience in clinical research, drug development or healthcare environment will be required

1. Experience

• Minimum of 5 years clinical database development experience. Alternatively, must have proven experience in all primary job functions Prior experience using computerized information systems preferred.

• Ability to read, write, and speak fluent English.

• Clinical trials support or pharmaceutical industry experience preferred.

• Knowledge of ICH and local regulatory authority drug research and development regulations preferred.

1. Expertise and know-how

• Has developed an in depth understanding of database development processes, SOPs and working guidelines

• Ability to supervise projects and other individuals

• Knowledge of ICH / GCP regulations

• Working knowledge of CDISC

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 priorities 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.

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.