长沙招聘

职位描述：
Responsibilities:
General:
?Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
?Perform activities and provide technical expertise to set up and test data collection including but not limited to electronic data collection (EDC), case report forms (CRFs), Patient Reported Outcome (PRO), electronic data loading, PK/PD data acquisition, medical lab normal ranges, randomization and data integration, etc.
?Create and write programs to assist data manager to ensure study data quality
?Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
?Able to resolve conflicts, influence and communicate with key stakeholders and customers.
eData Processing & PK/PD Functions:
?Work with Study Team to define the electronic data, PK/PD data, lab tests, and lab codes.
?Develop Data File Specifications, PK/PD Definition Files, and translator programs, create test plan, conduct UAT testing, load eData files, and maintain documentations for electronic data receipt
?Request reconciliation files from vendors and process files to retain the blind for PK/PD data management review.
?Work with Central/Analytical labs and Clinical Assay Group to troubleshoot issues related to sample collection, data transfer and management.

Database Design Functions:
?Design, create and test clinical database to ensure database quality.
?Define investigator center assignments and patient positions in study database, and ensure consistency between the tracking database and the study database.
?Ensure data collection tools and databases align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.
Medical Lab Functions:
?Coordinate data management and vendor interaction related to lab tests coding, unit conversion, and normal ranges setting for lab data integration, review, and reporting.
?Assist project teams in lab reference range page design, screen testing, and QC.
?Provide scientific knowledge and training about lab testing and clinical database to study teams, internal/external lab vendors when needed.
?Enter lab normal range, unit, unit conversion into EDC or data management system

Requirements
?Bachelor’s degree or above of equivalent experience in a scientific discipline required
?Technical expertise and business experience in supporting clinical trials database development, data acquisition, medical lab data collection (lab tests, units, and normal ranges), etc.
?Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
?Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
?Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills. 举报 分享

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。