Clinical Project Manager
Job Location:
Monthly Salary:
Posted on:
Vacancies:
Job Summary
JOB DESCRIPTION:
Primary Job Function
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.
Main Responsibilities
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.
Background & Education Required
Industry experiences:
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
Language Skills:
Fluent in writing and oral communication in Chinese and English
Computer Skills:
Microsoft Office (Word Excel Access PowerPoint). Experience with advanced technologies (e.g. artificial intelligence) to manage clinical studies is a bonus.
Mobility:
10-20% travel
Certificate Required:
GCP training
Education:
A postgraduate degree in nutrition medicine pharma or life science disciplines is required.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Research and Discovery
DIVISION:
ANRD Nutrition Research & Development
LOCATION:
China > Shanghai : 1036 Tianlin Road Caohejing Business Park SBP Phase III
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
