南京招聘

General Summary

l  Conduct QCSV to assist the assigned operational staff in improving compliance with relevant ICH-GCP, SOPs, applicable regulatory requirements and guidelines.

l  Contributes to site quality issue resolution.

l  Provides advice and support to relevant key stakeholders with regards to quality control and corrective/preventive actions

 

Accountabilities

l  Provides advice and support to operational teams including Clinical Research Associates, Line Managers and other key stakeholders on all aspects of GCP compliance.

l  Preparation for the QCSV, including communication with study team, review site TMF documents, hold Pre-visit meeting.

l  Conducting on-site QCSV and Issue Escalation.

l  Follow up the QCSV, including hold post-visit meeting, complete QCSV report, support Root Cause Analysis and CAPA completion.

l  Works in close cooperation with operational staff to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.

l  Supporting on Quality Issues resolution.

l  Developing And Delivering Lessons Learned (LL).

l  Informs Quality Control Manager, Head of Clinical Operations and line management of Operational staff and Quality Assurance of quality issues according to SOPs.

l  May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with the Head of Clinical Operations and as required by the applicable SOPs.

l  Acts as the primary contact between Quality Control Manager and Project team and Clinical Operations on clinical quality matters-on the level of the assignment, attend meetings/teleconferences.

l  Works closely with Quality Assurance and assigned business staff in case of suspected misconduct as required by the applicable SOPs.

l  Performs any other reasonable tasks as required by the role.

l  May assume a customer (site or sponsor) facing role to the extent required by the assignment and applicable SOPs.

 

Qualifications

l  Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 5 years’ experience in Clinical Monitoring, preferably including experience in a role equivalent to GCP auditor/QC specialist experience is preferred, Lead CRA/Clinical  Team Lead; or equivalent combination of education, training and experience

l  Knowledge of National and International Regulations and Drug Development processes

l  Knowledge of CRO or Pharmaceutical industry operations

l  Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers

l  Excellent verbal and written communication skills, interpersonal skills

l  Excellent organizational skills

l  Fluent in English

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。