- Manage QC team and QC activities in China.
- Drive global KQIs and country specific quality performance within China.
- Support local process management and training delivery where applicable.
- Provide management and oversight for developing and implementing clinical management methodology standardization, driving continuous improvement/operational excellence across CDCS with a focus on Clinical Management.
- Define and lead initiatives to improve quality, efficiency and user experience in how Covance conducts business and measures performance.
- Perform changes and departmental management as the company delivery platform evolves.
♦ University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution
♦ In lieu of degree or certification,
o 6 years supervisory in health care
o and at least four (4) years clinical research experience
♦ Masters or other advanced degree
♦ In depth knowledge of ICH GCP
♦ Working knowledge of Covance SOPs
♦ Minimum (5) years of clinical research industry experience
♦ Minimum 2 years of quality management experience
♦ Experience managing projects in a virtual environment
♦ Learning to handle multiple competing priorities
♦ Demonstrated ability to utilize resources effectively on a moderate sized, cross-functional project
♦ Financial awareness of financial control procedures (i.e., costing systems, time reporting)
♦ Learning to inspire effective teamwork and motivate staff within a matrix system
♦ Developing confidence to lead by example and to encourage team members to seek solutions independently
♦ Good communication, planning and organizational skills
♦ In-depth knowledge of clinical operations processes
♦ Ability to review and report relevant data
♦ Ability to work independently
♦ Ability to negotiate and liaise with stakeholders in a professional manner
♦ Ability to present to staff at all levels
♦ Advanced computer skills with an ability to understand, access and leverage technology alternatives
♦ A working knowledge of ICH GCP, US FDA regulations, and regulations applicable to local office
♦ Broad knowledge of drug development process
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