Senior Clinical Database Programmer

Job Purpose:

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 Accountabilities:

Accountability Supporting Activities

Setup Database • 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.

• Accountable for first time quality on all deliverables.

• Provide feedback for study programmers on the creation of eCRF’s

following SOPs and internal process guidelines.

• Provide input into and negotiate database setup timelines. Ensure that

timelines are adhered to by:

• Actively assume activities on a project as required.

• Monitor project resourcing and identify changes in scope.

• Assist project teams in the resolution of problems encountered in

the conduct of their daily work to ensure first- time quality.

• Interact with Sponsors and Data Management Leaders as the key contact

with regard to programming related issues.

• Provide technical support and advice to the internal team.

• Ability to 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 Project

• Assist in providing technical solutions to internal or external client

enquires.

• 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 levels 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.

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.

• 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

Act as a mentor and/or

SME

• 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.

QualificationsSkills:

• Excellent English written and oral communication skills.

• Demonstrate 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.

• Work effectively in a quality-focused environment.

• Demonstrate strong organizational skills, ability to manage competing priorities, and be

flexible to change.

• Business/Operational skills that include customer focus, commitment to quality management

and problem solving.

• Good business awareness/business development skills (including financial awareness).

• Work effectively in a quality-focused environment.

• Strong leadership ability.

• Ability to create, maintain and define strategies to improve the efficiency of running a clinical

trial.

• Demonstrate commitment to refine quality processes.

Knowledge and Experience:

• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).

• Experience working with at least one system used within the Clinical Trial process (e.g.

SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting).

• Relevant Clinical Trial industry experience.

• 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.

Education:

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

experience.