北京外资500强制药公司招聘临床数据（DM）

shiyiming

JOB SUMMARY
Briefly summarize the primary purpose or function of the job (why does it exist?):

The  Clinical Data Specialist (CDS) is responsible for developing and implementing Data-Management planning for specific studies, for ensuring that the activities are completed according to agreed standards and timelines and for coordinating ongoing data management to support the flawless conduct of a clinical trial, by acting as representative in the study team.



KNOWLEDGE AND SKILL REQUIREMENTS (Minimum requirements for assignment to this job.)

Knowledge And Skills:



Formal Education And/Or Experience Required:

Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciencecs) or equivalent experience (at least 3 years) in clinical data management.
Oral and written English communication skills.     


Knowledge And Skills Desirable But Not Essential:

Knowledge of sanofi-aventis SOPs. Remote management experience. Management of outsourced activities.     






PRINCIPAL DUTIES AND RESPONSIBILITIES (LIST 4-7)

Briefly describe the major duties and responsibilities for which the job is held accountable (please rank in order of importance.)
               
RANK        MAJOR DUTIES & RESPONSIBILITIES (what the job does)        END RESULTS EXPECTED
(why is it done/impact)
1.        Primary contact between CDM and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding, CRF design, DSD) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Project Leader. Proposes solutions for data management issues that arise during the conduct of a study

        Clear and effective Data Management Plan for each study. High quality Database locked per timelines. Interim deliverables, such as interim analyses databases, delivered according to team specifications and timelines.
2.        In charge of the development of protocols, CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge.         High quality CRFs, Data Management Plan, including Data Validation Plan, and Data Review Report.
3.        Coordinates CDM study teams (Clinical Data Coordinators, contractors) assigned to support studies.         Effective leadership of CDM study team. Clear assignment of individual tasks and adequate use tracking tools to monitor study progress.
4.        Continually evaluates CDM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function. Deputizes for the Project Leader Data Management, when appropriate. Participates in the implementation of department initiatives.         Best practices applied to all aspects of CDM project/study activities.

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