Posted:

Clinical Data Specialist_010m

Company
- A world famous medical industry

Location
- Beijing

Responsibility

Main Tasks:

- Review & comment on protocols, especially with focus on standardization
of data collection, use of Case Report Form standard modules.
- Supervise the set- up of CRF to ensure that contents, composition
and design confirm with the respective protocol, the project standard
and all applicable SOPs.
- Co-ordinate the set-up, formatting, sending and receipt of electronic
data with laboratories (CDP trials).
- Set up database in Oracle Clinical for local and CDP trials.
- Create annotation, TVP, TDP and editing validation and derivation programs.
- Perform query management and DCFs generation and tracking.
- Generate trial documentation such as Data handling protocol/Report
and Raw Data Listings, organize database release meeting.
- Prepare related documentations for statistical analysis
and clinical trial report.
- Contribute to reports including clinical reports in the form
of listings based on raw data in collaboration with trial members.
- Make out electronic data tracking and data extracting method.
- Organize, plan and schedule his/her own participation in projects.
Plan, co-ordinate, supervise and evaluate the DM activities
for local clinical trials and CDP trials.
- Bring to the attention of the DM alternative/additional tools,
facilities, methods, techniques.
- Contribute to generation of a co-operation and collegial atmosphere
within the trial team and department.
- Perform Data coding with WhoDrug and MedDRA dictionary in TMS system.

Requirements

- Bachelor's degree is required, preferably in biomedical related
field or computer related field.
- In-depth knowledge of the data management process.
- Computer proficiency required; familiar with SQL language,
Programming skills of database software, i.e. Oracle, SAS,
or Access required.
- Comprehensive knowledge of the structure of database.
- Excellent spoken and written English.
- 2-3 years working experience in Data management work,
preferable in the field of relation database system.


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