上海招聘

·      Responsible for ensuring the completeness quality and integrity of the subject data in the clinical trial database

·      Responsible for overseeing and managing all DM activities for the study according to regulations applicable Standard Operating Procedures (SOPs) and Processes

·      Serves as a member of the study team(s) and is accountable for all DM-related communications, specifications, and documentation.  This includes, but is not limited to the Case Report Form (CRF), Data Management Plan (DMP) and the Data Validation Plan (DVP), etc.

·      The LDM is responsible for the overall quality and integrity of the database with respect to local authority requirement and industry standards

Responsibilities

2  Serves as the key contact DM in Data Management function role to provide oversight and advice to the clinical study team(s) regarding the DM activities and deliverables

·      Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across clinical research functions

·      Provides input to the DM related activities associated with regulatory inspections/audits

2  Development and oversight of DM processes and standards and functional leadership

·      Works with the cross function teams to provide input into collection standards and processes based on industry best practices

·      Assesses HBM DM needs and areas of improvement and recommends changes to the operating model

2  Management and oversight of vendor contracts

·      Reviews, assesses and manages DM delivery against contracted service items and overall DM performance

·      Manages all DM timelines and DM Deliverables for assigned studies

 2  Operational Responsibilities

·      Accountable for the execution and overall quality of DM activities and deliverables.

·      Acts as the single point of contact for all data management deliverables for the study team during the study set-up phase, accountable for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.

·      Provide guidance and supervision to CRO data management team working on the study

·      Accountable for the overall quality and completeness of the activities defined in Data Management Plan (DMP)

  Qualifications (the minimum skills, knowledge and experience required for the role)

·      B.A./B.S. or equivalent with 3-5 years experience in Clinical Data Management

·      Good understanding of GCP and regulatory requirements as they relate to data management systems and activities

·      Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)

·      Demonstrated understanding of clinical data system design / development / validation and system integration

·      Excellent written and verbal communication skills

·     Demonstrated basic knowledge of Windows Environment and its applications (Word Excel PowerPoint Project etc.)

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.