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Senior Clinical Database Programmer (Bloemfontein, South Africa)

Parexel International Corporation

South Africa - Any Region - Home Based

The Senior Database Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies. In addition, the Senior Database Programmer can assist the Database Primary or Technical Lead role on projects, and liaise with sponsors, Data Management Lead and other functional areas as required.

General areas of responsibility also includes: eCRF design, edit check programming and integration of third party systems with the EDC databases. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.QualificationsESSENTIAL EXPERIENCE REQUIRED:-

• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).

• Experience working with at least one system used within the Clinical Trial process (e.g. SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting).

• Relevant Clinical Trial industry experience.

• Knowledge of the programming and reporting process within GDO.

• Knowledge of SOP's/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.

• Excellent English written and oral communication skills.

• Demonstrate ability to learn new systems and function in an evolving technical environment.

• Attention to detail.

• Ability to work together with a team (including international teams as required) as well as independently.

• Work effectively in a quality-focused environment.

• Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change

Job posted: 2021-02-05

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