Position Purpose

·           Responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database.

·           Ensure the consistent use and application of applicable data standards.  The ultimate objective is to ensure data quality and consistency across programs and repositories.

·           Responsible for data management activities within a clinical trial, according to regulations, applicable Standard Operating Procedures (SOPs) and Processes.

·           Works with the global study team to meet the study objectives.

Responsbility

 General

·         Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.

·         Ensures Conformance to Pfizer Data Standards.

·         Actively participates in monthly project review meetings.

·         May participate in Therapeutic Area (TA) specific process improvement initiatives.

Hands-on data management responsibilities (Data Manager):

·         Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.

·         Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.

·         Ensure timely set-up of clinical data acquisition and management tools and data validation.

·         Maintain study tracking to ensure timely CRF retrieval, data entry and data cleaning activities.

·         Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and review of data listings to verify quality and completeness of data.

·         Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.

·         Reconcile the patient database with the Serious Adverse Event database.

·         Document all efforts of data management and file all responsible documents.

Experience

Bachelor degree or equivalent in a natural/medical science, data management or related discipline. 

该岗位目前招聘实习生有留用机会（实习生一周3天，4-6个月长期实习），应届生或1-2年工作经验也可申请。