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Home Page> News > Clinical Research Manager

Clinical Research Manager

 

Responsibilities:

1 Provide ongoing support to project leaders, perform and manage day-to-day clinical operations, and ensure that the medical tasks assigned are carried out in compliance with ICH-GCP, local laws and regulations, and RealData's SOPs.
2 Work closely with project leaders to oversee clinical trials in order to ensure the quality and integrity of data and the safety and efficacy of the trial drug.
3 Conduct co-monitoring activities when required.
4 Coach PMs and CRAs in their therapeutic areas.
5 Assess the competencies and skills of CRAs on a regular basis and maintain a feedback system on the quality of their work.
6 Ensure that CRAs follow RealData's safety reporting procedures, RealData's SOPs, and all applicable regulatory requirements.
7 Ensure that CRA team members and managers receive the appropriate training.
8 Meet with team members on a regular basis to ensure that their needs are met and their responsibilities are understood.

Qualifications:

1 A bachelor's degree in a medical, health, or science related area (MS/MD preferred and MBA a plus).
2 Minimum of 3 years of related experience in clinical trial management or a related field.
3 Thorough understanding of Good Clinical Practice (GCP) and SFDA regulations.
4 Thorough understanding of the clinical drug development process and team-based matrix management.
5 Demonstrated ability to identify and solve problems independently.
6 Demonstrated ability to plan and organize effectively.
7 Ability to lead a cross-functional team.
8 Strong customer relations skills and sensitivity towards customers concerns.
9 Effective spoken and written English communication skills, including presentation skills.
10 Proven record of successful completion of complex tasks with minimal supervision.
11 Intermediate to advanced computer skills in standard office applications.
12 Travel may be required. Travel time is dependent on project needs.

Locations
Quantity
   Shanghai, China    10
   Hangzhou, China    5
   Wuhan, China    5
   New Jersey, U.S.A.    5
   Singapore    2


 

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