The Clinical Database Programmer 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 include: eCRF design, edit check programming, edit check validation and integration of third-party systems with the EDC databases. All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

Key Accountabilities:

Setup Database

• 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.

• Accountable for first-time quality on all deliverables.

• Provide feedback for study programmers on the creation of eCRFs following SOPs and internal process guidelines.

Support Project

• Assist in providing technical solutions to internal or external/client enquiries. 

• 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 area.

• Ensure adherence to service level agreements regarding the turnaround time from the point when specifications are finalized.

Documentation 

• 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. 

• Maintain technical documentation that is applicable to the Clinical Database.

Support Initiatives 

• Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes. 

Skills:

• Excellent communication skills, with fluency in written and spoken English.

• Demonstrated 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.

• Demonstrate strong organizational skills, the ability to manage competing priorities, and flexibility in adapting to change.

• Business/Operational skills that include customer focus, commitment to quality management and problem solving.

• Work effectively in a quality-focused environment.

Knowledge and Experience: 

• 3 to 5 years of experience in Clinical Data Programming.

• 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, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.  
  

Education:

• Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.