Principal Clinical Database Programmer (Bloemfontein)
Parexel International Corporation
Bloemfontein, Orange Free State, South Africa
The Principal Database Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. In addition, the Principal Database Programmer can fill the Database Primary (late phase) or Technical Lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as required. General areas of responsibility also include eCRF design, edit check programming and integration of third party systems with the EDC databases.Qualifications• 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 SOPs/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.
• Team and Project leadership experience required.
• Proven record of leading a team and a large scope of projects in a GDO, Technical, Clinical, Medical or Statistical environment.