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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Clinical Database Programmer II

Job ID 82049BR India - Any Region - Home Based
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 eCRF’s
following SOPs and internal process guidelines.
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.
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.
Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.

Qualifications

• Good 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.
• Work effectively in a quality-focused environment.
• 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.

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