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.Qualifications
· Experience in at least one programming environment (e.g. SAS, CDMS, EDC, SQL, VB, Java).
· 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.
· Experience working with at least two system used within the Clinical Trial process (e.g. SAS, CDMS, EDC: Inform, RAVE, DataLabs, Medrio, Veeva, CTMS, Medical Safety Reporting) is desirable. Build Certified in at least one system, if available
· Strong experience in clinical research industry or similar field is required
· Knowledge of Software Development Life Cycle (SDLC) methodologies. Knowledge of GCP, 21CFRPart11 and other relevant ICH/regulatory guidelines
Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience
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