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欢乐生肖网上投注Project Manager

Responsibilities:

1 Coordinate and supervise all aspects of clinical studies and make sure that they are conducted in accordance with FDA/SFDA regulations, ICH-GCP guidelines, and RealData's or our sponsor's SOPs.
2 Coach CRAs in their specific area.
3 Contribute to the development of protocols and CRFs.
4 Provide job skill recommendations to CRAs.
5 Ensure protocol compliance across all sites.
6 Participate in site selection, initiation, monitoring, and closeout activities.
7 Generate clinical project plans, including the timeline projection and monitoring strategy.
8 Review CRA trip reports and correspondence.
9 Prepare and implement project-specific training programs and presentations for internal and external clinical teams.
10 Provide leadership, guidance, and mentoring to the clinical team.
11 Generate regular written status reports for both internal and external use.
12 Maintain awareness of developments in clinical research, GCP, and various therapeutic areas.
13 Make recommendations regarding monitoring safety, eligibility, enrollment, and data consistency.
14 Organize and participate in investigator meetings, including presentations.
15 May function as a project leader, coordinating multi-function project teams and participating in budget and contract development.

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 - 5 years of experience in clinical research or clinical trial monitoring as a CRA in a pharmaceutical or CRO company.
3 Minimum of 2 years of experience in clinical trial management.
4 Proficient in SFDA regulations and ICH-GCP guidelines.
5 Knowledge of and experience in clinical trial design, analysis, and reporting (advanced clinical/pharmacology training preferred).
6 Knowledge of the medical, scientific, and clinical research aspects of pharmaceutical trials.
7 Demonstrated ability to plan and organize effectively.
8 Demonstrated ability to identify and solve problems independently.
9 Demonstrated ability to write protocols, CRFs, and clinical trial reports independently.
10 Ability to mentor and support clinical research staff.
11 Effective oral and written English communication skills are a must.
12 Excellent computer skills.
13 Must be a self-motivated and positive team player.
14 Must be able to travel if required.

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