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.
Key Responsibilities: Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable. Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements. Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines. Interact with Sponsors and Data Management Leaders as the key contact with regard to programming related issues. Lead and support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies on multiple projects simultaneously. Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required). Support to build or integrate systems within the GDO Area. Execute other programming languages and processes within the GDO area. (e.g. Clinical Trial Management System, Safety Systems, Coding Systems). Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams. Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes. Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies. QualificationsIdeal candidate will possess: Bachelor’s degree (or equivalent) in a relevant science discipline. 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. Ability to work together with a team (including international teams as required) as well as independently. Work effectively in a quality-focused environment. Strong organizational skills, ability to manage competing priorities, and be flexible to change. Business/Operational skills that include customer focus and commitment to quality management. Good business awareness/business development skills (including financial awareness). Excellent English written and oral communication skills. Ability to travel as required.
- Attention To Detail
- Business Awareness
- Business Development
- Case Report Forms
- Clinical Research
- Clinical Systems And Networks