中文版
Career ResourcesSign InEmployers

JOB SEEKERSEMPLOYERSABOUT US

jobs → → Clinical Manager

Foreign HR

Job Summary

Company
Foreign HR

Location
Shenzhen

Job Type
Full-time

Years of Experience
5+ years

Salary
Negotiable / Month

Career Level
Manager(Manager/Supervisor of Staff)

Job Reference Code

Clinical Manager

Location: Guangdong

Post Date: Jan 11, 2017

Our Shenzhen-headquartered group client is one of the global leading providers of diagnostic ultrasound devices. Since they established in 2002, they have pursued their mission of bringing innovative, high-performing, yet affordable equipment to their customers. 


Responsibilities:


1/ Executes clinical trial activities that support international studies to include appropriate applications and notifications, regulatory filings and approvals;

2/ Lead the development of core clinical documents (clinical study protocol, case report forms, informed consent forms, clinical study agreements, investigators manuals, investigator files, and other necessary documentation for study initiation);

3/ Secure and maintain all documentation necessary to comply with FDA, CFDA and EU governing regulations;

4/ Ensures clinical studies meet timelines and are operating within the guidelines and requirements of federal, state, and international laws, rules and regulations;

5/ Develops and manages the clinical studies budget. Regularly audits expenditures versus budget to identify and correct errors. Partners with management to prioritize spending;

6/ Assists site coordinators, investigators and field clinical staff, in collecting data in a timely manner which meets the protocol requirements;

7/ Ensures clinical studies are conducted in compliance with investigational plan;

8/ Effectively communicate relevant information and progress of clinical trials activity to executive management;

9/ Maintains database cleaning, and archiving of data.


Requirements:


1/ Minimum BS or BA; focus in biological science or research or equivalent preferred.  Advanced degrees preferred;

2/ 5 or more years of experience in medical device clinical management. Experience in Gastroenterology field is a plus;

3/ Proficient knowledge and understanding of Good Clinical Practice (GCP), applicable federal and international regulations;

4/ Detailed knowledge of U.S. and European clinical trial requirements, including regulations and guidelines. Additional preference with knowledge of clinical trial requirements in China;

5/ Exceptional interpersonal skills and ability to effectively work with teams and promote collaboration;

6/ Excellent verbal and written communication skills, ability to interact with all levels of management within the organization and to external business contacts;

7/ Good practical knowledge of common software packages (e.g., MS Word, Excel, Power Point, etc.);

8/ Able to work with minimal supervision, set priorities, and be flexible within a fast-paced environment;

9/  Able to work individually as well as part of a team;

10/ Able to write and read English and Chinese language.


If you wish to apply for this vacancy, please send your CV + description of your current situation to pro@foreignhr.com

Email subject line: “Clinical Manager [Shenzhen]