Ensure AN-sponsored clinical trials are being planned, conducted, recorded, and reported in accordance with the study protocol, AN Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulatory requirements.
- Responsible for planning, execution, and management of AN clinical research projects and programs in the Greater China area (mainland China, Hong Kong and Taiwan), including:
1)Set up the clinical trial
2)Selection of sites and investigators
3)Provide input for study protocols from the execution point of view
4)Manage CRO and SMO staff
5)Site management
6)Financial expense management according to the budget
7)Risk management to ensure study quality and timeline
8)Produce and/or evaluate study reports and other relevant documents in time together with study scientist(s)
9)Other supporting activities for the success of the projects, e.g., logistics, sample management.
- Work closely with the cross-functional team (including the global clinical research team, medical safety, regulatory, etc.) throughout the lifecycle of clinical trials.
- Work with the global clinical research team and the local medical affairs team on managing investigator-initiated studies, as assigned.
- Engage with academic and medical researchers for collaborative opportunities and represent AN as a clinical trial expert at educational programs and scientific meetings.
1)5 or more years of clinical research experience (PM and/or CRA experience is preferred), familiar with clinical research and GCP
2)Good knowledge of clinical trial principles, clinical study protocols, and standard practice in China
3)Basic knowledge of nutrition and/or the China FSMP registration clinical trial guideline is highly preferred
4)Experience with China/Taiwan FSMP registration clinical trial is a bonus
5)Position experiences:
6)5 or more years of clinical trial management experience at operational levels in the pharmaceutical or nutrition industry
7)Experience with clinical trials conducted in China
Fluent in writing and oral communication in Chinese and English
Microsoft Office (Word, Excel, Access, PowerPoint). Experience with advanced technologies (e.g., artificial intelligence) to manage clinical studies is a bonus.
10-20% travel
GCP training
