職位描述
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職位職能:
??醫藥技術研發管理人員??臨床研究員
職位描述:
JOB TITLE: Clinical Research Manager
Location: Beijing
PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Responsible for trials with complex protocols, which require technical specialization, requires the ability to interface with investigators/doctors. Provides guidance & advice to more junior level CRAs & Project Teams, Summarize and share with RA people CT study experience. Set up CT strategy and overall control CT timeline both imported products and local product.
1.Ensure the implementation of project plans as assigned.
2.Be responsible for plan and protocol writing, data controlling, data reporting, and final report writing.
3.Be responsible for site selection, site qualification, site monitoring, site management, site administration and registry management for clinical studies according to GCP, ICH Guidelines, and local regulation.
4.Be responsible for CROs selection as required.
5.Coordinate complex studies at multiple sites potentially involving teams of CRA(Clinical Research Associate).
6.Prepare clinical trials, including selecting & qualifying sites, researching & writing trial plans and protocols, setting-up, equipping & training sites.
7.Prepare clinical trials, including selecting & qualifying sites, researching & writing trial plans and protocols, setting-up, equipping & training sites.
8.Conduct & monitor clinical trials, coordinating all contact with the sites, problem solving, analyzing data, as well as building & maintaining relationships with investigators & the sites.
9.Select CROs as appropriate and negotiate related contracts.
10. Lead reviews of data periodically & keep Project Team informed.
11.Lead problem solving & troubleshooting efforts on technical issues.
12.Lead preparation of final trial reports & close the trial.
13.Lead technical reviews to launch & close trials.
14.Collaborates with investigators on scientific posters & papers.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
1.5-7 yrs clinical research experience in China,
2.MSc in a scientific field (ex biology, pharmacy,) ;
Education & Knowledge:
1.Scientific background preferred
2.Deep knowledge of monitoring procedures.
3.Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.
4.Basic knowledge of clinical trial process.
5.Ideally knowledge in: In vitro diagnosis; Chinese regulation;
6.Chinese native speaker; Fluent English.
