职位描述
The Database Programmer I /II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies. 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 Accountabilities
-Deliver best value and high quality service.
- Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized.
- Ensure quality control (QC) on all process and technical activities related to: trial set-up and maintenance, and/or implementation of system applications and upgrades/changes to those applications as required are performed in accordance with corporate quality standards, SOPs/Guidelines/Work Instructions, ICH-GCP and/or other local or international regulatory requirements.
- Check own work in an ongoing way to ensure first-time quality.
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance.
- Proactively participate in quality improvement initiatives.
- Ensure compliance with SOPs/Guidelines/Work Instructions, ICH-GCP and any other applicable local or international regulations and participate in internal/external audits and regulatory inspections as required.
- Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting and other programming language usage and processes within the GDO and medical areas.
- Provide relevant training and mentorship to staff and project teams as appropriate.
- Assist project teams in the resolution of problems encountered in the conduct of their daily work.
- 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.
- 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.
- Perform small to medium size ad-hoc programming tasks.
- Implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved operational efficiencies.
- Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.
- Assist in providing technical solutions to internal or external client enquires.
- Create Clinical Database documentation.
- Support Quality Management efforts through the production and maintenance of technical supporting documentation and ensure that documentation is compliant with corporate quality standards, SOPs/Work Instructions/Guidelines, appropriate regulations and validation requirements.
- Coordinate the filing of related documentation in a secure central file repository.
- Maintain technical documentation that is applicable to the Clinical Database.
- Maintain all supporting documentation in accordance with SOPs/Work Instructions/Guidelines to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.
