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Clinical Affairs Supervisor

Location: Shanghai, China
Position Type: Fixed-Term

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

Responsible for trials with protocols and CT report, which require technical specialization, requires the ability to interface with investigators/doctors;
Responsible for the conducting clinical trial, which require clearance of the CT process;
Provide guidance & advice to more junior level CRAs & Project Teams;
Assist department to set up CT strategy and overall control CT timeline;
Assist department to build SOPs relate with CT.

 

MAIN ACCOUNTABILITIES

Establish project plan with clear timeline and deliverables and ensure the implementation of  the defined plan;
Responsible for plan and protocol writing, data controlling, data reporting, and final report writing and guiding junior CRAs;
Responsible for site selection, site qualification, site monitoring, site management, if necessary negotiate site contracts;
Responsible for CROs selection as required;
Coordinate complex studies at multiple sites potentially involving teams of CRA(Clinical Research Associate);
Prepare, conduct & monitor clinical trials, coordinate all contact with the sites, problem solving, analyzing data; lead problem solving & troubleshooting on technical issues;
Lead reviews of data periodically & keep Project Team informed;
Lead preparation of final trial reports & close the trial.

 

KNOWLEDGE, LANGUAGE AND EXPERIENCE

1.MSc in a scientific field (biology, pharmacy), Medical  background preferred
2.5-7 years' clinical research experience in the relevant industry, IVD industry with team management experience preferred
3.Good knowledge of clinical trial process and the process of sites
4.Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements, Chinese regulation preferred
5.Chinese native speaker with fluent English  in both written and oral

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