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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

Foreign HR is one of the leading recruiters in Asia, connecting international talents with the latest Chinese employment opportunities. Headquartered in Beijing, we are a Chinese company with an international team, giving us global experience and local knowledge. Our business rests upon our principles of fairness, transparency and confidentiality. We verify all of our positions to ensure that our jobs are both legitimate and consistent as advertised.

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]