长沙招聘

Responsibilities 

1.    Participate the QC plan development of a clinical research project and ensure QC plan developed/executed properly in according with regulations/laws and company requirements.

2.    Prepare and conduct QC tasks per agreed QC plan; Inform Heads of Quality Management, Heads of the assigned business line and Quality Assurance of quality issues according to SOPs.

3.    Provide support and guidance to operational staff in risk management, non- compliance management, root cause analysis and CAPA development; Ensure QC findings resolved/closed and CAPA completion in line with company requirements and timeframe agreed with clients.

4.    Provide advice and support to operational team in improving compliance with GCP, SOP and applicable regulatory requirements and guidelines.

5.    Works in close cooperation with Quality Assurance team and assigned business staff to manage quality issue and non-compliance issues; Plan and implement corrective/preventive actions, as applicable according to company requirements.

6.    Support and ensure inspection or audit readiness and appropriate conduct and follow up serve as the primary liaison with Quality Assurance team, inspectors or auditors and control the activities during inspection or audit

7.    Act as the primary contact for Quality Assurance on clinical quality matters- on the level of the assignment , attend meetings/teleconferences.

8.    Prepare periodic reports to LM, QC function leader, Clinical Operation senior management team and to relevant stakeholders on quality related matters as required.

9.    Regularly complete regular quality trend analysis and provide lesson learned with Clinical Operation team and Project Management team.

10.  Provide advice and support for training plan/program designing of operational team and continuous operation process optimization; Contribute to specific quality improvement initiatives

11.  Perform any other tasks as required by the role or as assigned by LM

12.  Manage staff in accordance with organization’s policies and applicable regulations and ensure staff delivers high quality outcomes. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development; rewarding and discipline employees; address employee relation issues and resolving problems. Approve actions on human resource matters.

13.  Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interview process. Conduct onboarding training for new staff in conjunction with Human Resource and learning and Developing training programs.

14.  Evaluate office/home based onboarding/offboarding processes and optimize the process if needed. Develop standard processes to ensure that staff has the proper materials, systems access and training to complete job responsibilities.

15.  As assigned and with supports/guide from supervisor, evaluate quality metrics through regular review and reporting of findings. Collaborate with senior management and other functional leadership to improve efficiencies and quality.

16.  As assigned and with supports/guide from supervisor, participate and may take lead role in cross functional collaboration or cooperate initiative for process or quality improvement.

17.  As assigned and with supports/guide from supervisor, support with QC stand along biding activities and client facing.

18.  Coach lower level staff and ensure their works delivered in high quality.

Qualifications

1.    A College or Bachelor (or above) degree in life sciences, pharmacy, nursing or medical. At least 5 years’ experience in clinical trial operation or project management preferably experiences in a role equivalent to GCP audit/QC specialist.

2.    Proficient knowledge of ICH GCP and associated regulatory guidelines.

3.    Proficient English skills in listening, speaking, reading and writing.

4.    Excellent verbal and written communication skills, interpersonal skills

5.    Good ability to establish and maintain effective working relationships with coworkers, managers and clients/customers.

 

 

昆翎（ClinChoice）是一家致力于为生物医药和医疗器械客户提供高品质一站式服务的临床阶段CRO，服务包括临床运营、项目管理、生物统计、数据管理、注册事务、医学事务和药物警戒。昆翎已经在中国、美国、欧洲、印度、日本和菲律宾建立了主要的临床交付中心，目前在全球拥有1800多名员工，其临床运营团队覆盖了亚、欧、北美等七个国家和地区。

高盛直投部董事总经理、昆翎董事会成员许小鸥先生认为，“随着创新疗法在全球的增长，CRO公司提供高效、可靠的研发服务能力变得尤其重要。昆翎独特的价值主张结合了其对于本地市场的了解、国际药物研发的经验以及高效的团队执行能力。我们坚信公司强劲的管理层团队以及其高效的执行能力，将为昆翎的发展开启新的篇章。

昆翎是一家全球化的临床合同研究组织 (“CRO”)，在亚洲、北美洲和欧洲七个不同国家和地区拥有超过1800名临床研究专业人员。在全新品牌战略的引领下，昆翎将以“立足中国，服务全球”为己任，继续为全球制药、生物科技和医疗器械公司提供高质量、全方位服务的临床研究服务