Clinical Database Programmer I

Job Purpose

The Clinical Database Programmer I work with close supervision to support various programming activities related to clinical systems, and/or the application of computer and communication 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 to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems

• 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.
• 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

Support Projects & Technologies

• Assist in providing technical solutions to internal or external/client enquires.
• 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)
• Ensure adherence to service level agreements with regard to 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.

Skills:

• Ability to collaborate with global teams and work independently
• Good interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
• Demonstrate ability to learn new systems and function in an evolving technical environment.
• A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
• Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
• Commitment to first time quality, including a methodical and accurate approach to work activities
• Time management and prioritization skills in order to meet objectives and timelines
• Evidence of strong problem-solving skills including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
• Ownership and accountability relative to Key Accountabilities in Job Description
• Written and oral fluency in English

Knowledge and Experience:

• Experience in at least one programming environment (e.g. SAS, CDMS, EDC, SQL, VB, Java).
• Awareness 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 in clinical research industry or similar field is desired

Education:

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